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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001724-31 | EudraCT Number |
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Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment, while the majority of patients will eventually develop evasive resistance. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with the VEGF inhibitor, axitinib.Since this will be the first study of axitinib given in combination with crizotinib, the study will primarily assess the safety and tolerability of the combination regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axitinib in combination with crizotinib, escalation phase | Experimental | Dose Escalation Advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available |
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| Expansion Phase Cohort 1 | Experimental | Dose Expansion, Cohort 1: axitinib in combination with crizotinib Advanced renal cell cancer [RCC] with no prior systemic therapy |
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| Expansion Phase Cohort 2 | Experimental | Dose Expansion, Cohort 2: axitinib in combination with crizotinib Advanced renal cell cancer with at least one but no more than two prior systemic treatment regimens directed at advanced RCC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axitinib | Drug | Axitinib: tablets, dosage range 2 - 5 mg, given orally twice daily on a continuous dosing schedule in 28 days cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinib or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count<1000/mm^3 with single temperature of >38.3 degrees celsius or sustained temperature of 38 degrees celsius for >1 hour; >=Grade 3 neutropenic infection; >=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (>=Grade 3 toxicities [except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc>=501 msec) if persisted after correcting reversible causes, and failure to deliver >=75 percent (%) of dose of each study drug. | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drugs (crizotinib and axitinib) without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| Investigational Drug Services IUHSCC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31171735 | Derived | Michaelson MD, Gupta S, Agarwal N, Szmulewitz R, Powles T, Pili R, Bruce JY, Vaishampayan U, Larkin J, Rosbrook B, Wang E, Murphy D, Wang P, Lechuga MJ, Valota O, Shepard DR. A Phase Ib Study of Axitinib in Combination with Crizotinib in Patients with Metastatic Renal Cell Cancer or Other Advanced Solid Tumors. Oncologist. 2019 Sep;24(9):1151-e817. doi: 10.1634/theoncologist.2018-0749. Epub 2019 Jun 6. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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To understand the pharmacokinetic (PK) effects of crizotinib on axitinib, a 7-day lead-in period of single-agent axitinib directly preceding the administration of the crizotinib and axitinib combination was included prior to Cycle 1 in the dose escalation phase of the study.
This study was conducted in 2 parts: Part 1 (Dose escalation part to determine maximum tolerated dose [MTD] of axitinib in combination with crizotinib), Part 2 (Dose expansion part to assess the safety and tolerability of axitinib in combination with crizotinib at MTD determined in Part 1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Escalation Part |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2016 | Feb 21, 2018 |
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| crizotinib | Drug | Crizotinib: capsules, dosage range 200-250 mg, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle. |
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| axitinib | Drug | Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles. |
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| crizotinib | Drug | Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle. |
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| axitinib | Drug | Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles. |
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| crizotinib | Drug | Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle. |
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| First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drugs (crizotinib and axitinib) in a participant who received study drugs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03 | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities | Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included haemoglobin (anemia, haemoglobin increased), lymphocytes (lymphopenia, lymphocyte count increased), neutrophils, platelets and white blood cells. Number of participants with hematological abnormalities by grades (as per NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities | Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters/abnormalities included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia and gamma glutamyl transferase Number of participants with biochemistry test abnormalities by grades (NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value | ECOG-PS: used to assess how disease affected the daily living abilities of participant. It ranges on the scale from: 0-5 (0=fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity but ambulatory/able to carry out light/sedentary work;2=ambulatory [for more than (>)50%of waking hours], capable of all self-care but unable to carry out any work activities;3=capable of limited self-care, confined to bed or chair [for >50% of waking hours];4=completely disabled, not capable of any self-care, totally confined to bed or chair;5= dead, higher score=more functional impairment) and changes to worst status scores were presented. Baseline value=value collected prior to first dose of study drug on Cycle 1 Day 1. Worst post-baseline value=worst value between first dose of any study drug and end of treatment (EOT) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for ECOG-PS. | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) |
| Number of Participants With Maximum Increase From Baseline in QTc Interval | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Number of participants with maximum increase from baseline of less than (<) 30 milliseconds (msec), 30 to <60 msec and greater than or equal to (>=) 60 msec were reported. | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) |
| Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib | Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib | Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib | Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
| Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
| Apparent Volume of Distribution (Vz/F) of Axitinib and Crizotinib | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
| Percentage of Participants With Objective Response | Percentage of participants with objective response based on assessment of confirmed complete response [CR] or confirmed partial response [PR] according to Response Evaluation Criteria In Solid Tumors [RECIST] version1.1 were reported. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
| Dose Expansion Part: Duration of Response | Duration of response (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from first documentation of objective tumor response (complete response [CR] or partial response [PR]) until the first date that recurrent, progressive disease, or death (whichever occurred first). CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | From first objective response until first recurrent, disease progression, or death, whichever occurred first (up to 35 cycles, each cycle 28 days) |
| Dose Expansion Part: Progression-Free Survival (PFS) | PFS (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from start of study treatment to first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. PFS was not estimated in Dose Expansion Cohort 2 due to small sample size. | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles, each cycle 28 days) |
| Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers | Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR 3). Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days) |
| Dose Expansion Part Cohort 1: Change From Baseline in Serum Concentration of Circulating microRNAs (miRNA) at End of Treatment | Baseline, end of treatment (up to 35 cycles, each cycle 28 days) |
| Dose Expansion Part Cohort 1: Percentage of c-MET Positive Tumor Cell at Baseline in Relation to Objective Response Rate (ORR) | Percentage of c-MET positive tumor cell for objective response (complete response [CR] + partial response [PR]) is reported. Objective response was defined as CR and PR. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Baseline |
| Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET) | Plasma soluble protein biomarker included c-MET. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 3, 5; end of treatment (up to 35 cycles, each cycle 28 days) |
| Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint | Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR3). Ratio=value of serum soluble protein biomarkers at each time point to the value at baseline. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Wayne State University, Dept. of Oncology | Detroit | Michigan | 48201 | United States |
| University of Minnesota Health Clinics and Surgery Center | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Medical Center, Fairview IDS Pharmacy | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Physicians Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Cleveland | Ohio | 44106 | United States |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| John A Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| University Station Ophthalmology Clinic | Madison | Wisconsin | 53705 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| St Bartholomew's Hospital - Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| FG001 |
| Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg |
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| FG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| FG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| FG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| FG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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| COMPLETED |
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| NOT COMPLETED |
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| Dose Expansion Part |
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Safety analysis population included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG001 | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinib or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count<1000/mm^3 with single temperature of >38.3 degrees celsius or sustained temperature of 38 degrees celsius for >1 hour; >=Grade 3 neutropenic infection; >=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (>=Grade 3 toxicities [except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc>=501 msec) if persisted after correcting reversible causes, and failure to deliver >=75 percent (%) of dose of each study drug. | Per protocol analysis set:all enrolled participants who received at least 1 dose of study drug, experienced either DLT during first cycle,or completed first cycle observation period.Participants who lost to follow up before receiving at least 75% of planned first cycle dose due to reasons other than treatment-related AEs were not evaluable for DLT. | Posted | Count of Participants | Participants | No | Cycle 1 (28 days) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drugs (crizotinib and axitinib) without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Posted | Count of Participants | Participants | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drugs (crizotinib and axitinib) in a participant who received study drugs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Posted | Count of Participants | Participants | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03 | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Posted | Count of Participants | Participants | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities | Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included haemoglobin (anemia, haemoglobin increased), lymphocytes (lymphopenia, lymphocyte count increased), neutrophils, platelets and white blood cells. Number of participants with hematological abnormalities by grades (as per NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities | Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters/abnormalities included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia and gamma glutamyl transferase Number of participants with biochemistry test abnormalities by grades (NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point. | Posted | Mean | Standard Deviation | kilograms | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value | ECOG-PS: used to assess how disease affected the daily living abilities of participant. It ranges on the scale from: 0-5 (0=fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity but ambulatory/able to carry out light/sedentary work;2=ambulatory [for more than (>)50%of waking hours], capable of all self-care but unable to carry out any work activities;3=capable of limited self-care, confined to bed or chair [for >50% of waking hours];4=completely disabled, not capable of any self-care, totally confined to bed or chair;5= dead, higher score=more functional impairment) and changes to worst status scores were presented. Baseline value=value collected prior to first dose of study drug on Cycle 1 Day 1. Worst post-baseline value=worst value between first dose of any study drug and end of treatment (EOT) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for ECOG-PS. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Posted | Count of Participants | Participants | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) |
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| Secondary | Number of Participants With Maximum Increase From Baseline in QTc Interval | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Number of participants with maximum increase from baseline of less than (<) 30 milliseconds (msec), 30 to <60 msec and greater than or equal to (>=) 60 msec were reported. | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Posted | Count of Participants | Participants | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib | Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | Pharmacokinetic (PK) parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib | Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | Posted | Median | Full Range | hours | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib | Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
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| Secondary | Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol. | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Axitinib and Crizotinib | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | Data for this outcome measure was not collected due to change in planned analysis. | Posted | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 |
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| Secondary | Percentage of Participants With Objective Response | Percentage of participants with objective response based on assessment of confirmed complete response [CR] or confirmed partial response [PR] according to Response Evaluation Criteria In Solid Tumors [RECIST] version1.1 were reported. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) |
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| Secondary | Dose Expansion Part: Duration of Response | Duration of response (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from first documentation of objective tumor response (complete response [CR] or partial response [PR]) until the first date that recurrent, progressive disease, or death (whichever occurred first). CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | Subset of response evaluable analysis set included all participants with overall objective response of CR or PR who received at least 1 dose of axitinib and crizotinib and had baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for "dose escalation part", as pre specified in protocol. | Posted | Median | 95% Confidence Interval | months | From first objective response until first recurrent, disease progression, or death, whichever occurred first (up to 35 cycles, each cycle 28 days) |
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| Secondary | Dose Expansion Part: Progression-Free Survival (PFS) | PFS (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from start of study treatment to first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. PFS was not estimated in Dose Expansion Cohort 2 due to small sample size. | Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for "dose escalation part", as pre specified in protocol. | Posted | Median | 95% Confidence Interval | months | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles, each cycle 28 days) |
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| Secondary | Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers | Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR 3). Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Serum soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days) |
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| Secondary | Dose Expansion Part Cohort 1: Change From Baseline in Serum Concentration of Circulating microRNAs (miRNA) at End of Treatment | This outcome measure was not analyzed because of a change in planned analysis, due to the lack of strong evidence available supporting testing a hypothesis in the small sample set. | Posted | Baseline, end of treatment (up to 35 cycles, each cycle 28 days) |
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| Secondary | Dose Expansion Part Cohort 1: Percentage of c-MET Positive Tumor Cell at Baseline in Relation to Objective Response Rate (ORR) | Percentage of c-MET positive tumor cell for objective response (complete response [CR] + partial response [PR]) is reported. Objective response was defined as CR and PR. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Tumor Immunohistochemistry (IHC) analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement, and had confirmed objective response (CR+PR). | Posted | Mean | Standard Deviation | percentage of positive tumor cells | Baseline |
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| Secondary | Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET) | Plasma soluble protein biomarker included c-MET. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Plasma soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 3, 5; end of treatment (up to 35 cycles, each cycle 28 days) |
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| Secondary | Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint | Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR3). Ratio=value of serum soluble protein biomarkers at each time point to the value at baseline. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol. | Serum soluble protein biomarker analysis set: all enrolled participants who received at least 1 dose of any study drug, had at least 1 biomarker parameter from corresponding assay sample with at least 1 baseline biomarker measurement. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days) |
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Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 0 | 5 | 2 | 5 | 5 | 5 |
| EG001 | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 0 | 10 | 5 | 10 | 10 | 10 |
| EG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 2 | 21 | 8 | 21 | 21 | 21 |
| EG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. | 1 | 7 | 3 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v22.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pharyngeal mass | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2015 | Feb 21, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077784 | Axitinib |
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
Not provided
Not provided
| Disease progression |
|
| Sponsor decision |
|
| Adverse Event |
|
| Participant's non-compliance |
|
| Participant refused further follow-up |
|
| Changed to standard of care |
|
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| OG001 | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg |
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| OG001 | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| OG002 |
| Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg |
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
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| Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg |
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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|
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
|
| Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg |
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
|
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG002 | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG003 | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG004 | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
| OG005 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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| OG001 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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| OG001 | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor. |
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