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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003767-11 | EudraCT Number |
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Pfizer made a business-related decision on 04May2017 to terminate study based on change in portfolio prioritization, and is not due to safety or efficacy.
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The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309 and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.
The study has 2 parts:
Phase 1b (dose-finding cohorts) will be open label as patients will receive ascending doses of PF-04136309 in combination with nab-paclitaxel + gemcitabine. The observation period for dose-limiting toxicities (DLTs) will be from Day 1 to Day 28. Pharmacokinetic (PK) and pharmacodynamic (PD) properties of PF-04136309 will also be assessed. The criteria for dose escalation will be based on a modified toxicity probability interval (mTPI) method. After evaluating the safety and other results (eg, PK) from patients enrolled in the dose escalation cohorts, a dose level will be selected to be further evaluated as the Recommended Phase 2 Dose (RP2D). A minimum of 6 patients, up to 12 patients, will be treated at this dose level to establish it as the RP2D. To further evaluate safety and pharmacodynamics, the number of patients enrolled during this part of the study (Phase 1b) may be N up to 20. The study will stop if all PF-04136309 doses explored appear to be overly toxic.
Phase 2 randomized double blinded placebo control. Approximately 92 patients will be randomized 1:1 to receive the RP2D of PF-04136309 in combination with nab-paclitaxel + gemcitabine (ARM A; n=46) versus nab-paclitaxel + gemcitabine + placebo (ARM B; n=46). The primary objective will be the enhancement of efficacy in terms of PFS.
Patients will be treated as long as they are clinically benefiting from investigational product without unacceptable toxicity, objective disease progression, or withdrawal of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04136309 + Nab-p + Gem | Experimental | PF-04136309 oral dosing Nab-paclitaxel IV dosing Gemcitabine IV dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04136309 | Drug | PF-04136309 oral dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b] | DLT: Any of the following events occurred in the first treatment cycle and was attributed to the combination of PF-04136309 with nab-paclitaxel and gemcitabine where relationship with the combination could not be ruled out. Hematologic: Grade (Gr) 4 neutropenia lasting more than (>)5 days; febrile neutropenia; Gr≥3 neutropenic infection; Gr≥3 thrombocytopenia with Gr≥2 bleeding; Gr4 thrombocytopenia. Non-Hematologic: Gr3 toxicities (except: nausea and vomiting responding to prophylaxis and/or treatment and lasting less than (<)7 days from each chemotherapy infusion period; diarrhea responding to treatment and lasting <7 days; Gr3 QTc prolongation [QTc >500 milliseconds] [a DLT only if persisting after correction of any reversible causes]; Gr3 aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) increase lasting less than or equal to (≤)7 days); all Gr4 toxicities; delay of >2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. | Day 1 to Day 28 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b] | An AE was any untoward medical occurrence in a participant who received study drug 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. | 1 year |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b] | Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. |
| Measure | Description | Time Frame |
|---|---|---|
| PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Cmax of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) [Phase 1b] | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. |
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 |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31297636 | Derived | Noel M, O'Reilly EM, Wolpin BM, Ryan DP, Bullock AJ, Britten CD, Linehan DC, Belt BA, Gamelin EC, Ganguly B, Yin D, Joh T, Jacobs IA, Taylor CT, Lowery MA. Phase 1b study of a small molecule antagonist of human chemokine (C-C motif) receptor 2 (PF-04136309) in combination with nab-paclitaxel/gemcitabine in first-line treatment of metastatic pancreatic ductal adenocarcinoma. Invest New Drugs. 2020 Jun;38(3):800-811. doi: 10.1007/s10637-019-00830-3. Epub 2019 Jul 12. |
| 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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Phase 2 part of the study was not conducted due to early termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 30, 2016 | Aug 16, 2018 |
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| Nab-paclitaxel |
| Drug |
Nab-paclitaxel IV dosing |
|
|
| Gemcitabine | Drug | Gemcitabine IV dosing |
|
|
| 1 year |
| Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b] | Following parameters were analyzed for hematology laboratory test: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell (WBC) count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | 1 year |
| Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] | Following parameters were analyzed for chemistry laboratory test: blood urea nitrogen (BUN), creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, AST, ALT, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, Magnesium, phosphorous or phosphate. For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should have included albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time / international normalized ratio (PT/INR), alkaline phosphatase, total bile acids, and acetaminophen drug and/or protein adduct levels. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | 1 year |
| Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] | Following parameters were analyzed for urinalysis laboratory test: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase), urine dipstick for urine protein (if positive collected 24 hour and microscopic [reflex testing]), urine dipstick for urine blood (if positive collected a microscopic [reflex testing]). Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | 1 year |
| Progression Free Survival (PFS) [Phase 2] | PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. | 1 year |
| Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Cmax of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic coefficient of variation (CV) was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Cmin of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Cmin of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b] | t1/2 was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b] | Vz/F was determined by Dose/(AUCtau×kel). AUCtau is the area under the curve from time 0 to end of dosing interval and kel is the terminal phase rate constant. | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
| Ex Vivo Inhibition of Chemokine Ligand 2 (CCL2)-Induced Extracellular Signal Regulated Kinase (ERK) Phosphorylation in the Peripheral Blood [Phase 1b] | A drop in the CCL2-induced ERK kinase phosphorylation (pERK) biomarker level indicates target engagement (TE). | Cycle 1 Day 1 pre-dose, 2 and 6 hours post-dose, and 12 hours (pre-second BID dose-optional collection); Cycle 1 Days 2, 3 and 4 pre-dose |
| Number of Participants With Overall Survival (OS) [Phase 2] | OS was defined as the time from date of randomization to date of death due to any cause. For participants not expiring, their survival times were to be censored at the last date they were known to be alive. Participants lacking data beyond the day of randomization were to have their survival times censored at the date of randomization with duration of 1 day. | Up to approximately 13.5 months |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) [Phase 2] | An AE was any untoward medical occurrence in a participant administered a product or medical device 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. | Up to approximately 1 year |
| Number of Participants With Laboratory Abnormalities by Severity [Phase 2] | Hematology, chemistry, and urinalysis laboratory parameters were to be analyzed and graded by NCI CTCAE version 4.03. | Up to approximately 1 year |
| Objective Response Rate (ORR) [Phase 2] | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. | Up to approximately 1 year |
| Duration of Objective Response (DR) [Phase 2] | DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. DR data were to be censored on the day following the date of the last on treatment (including 28 day follow-up period after last dose) tumor assessment documenting absence of progressive disease for participants who did not have objective tumor progression and who did not die due to any cause while on treatment or who were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression. Participants who achieved a PR and then a CR were to have times calculated using the date of the PR as the first day. DR was only to be calculated for the subgroup of participants with objective response. | Up to approximately 1 year |
| Time to Progression (TTP) With the Double Combination PF-04136309 and Gemcitabine (Maintenance Therapy) After Interruption of Nab-paclitaxel [Phase 2] | This type of TTP was defined as the time from interruption of nab-paclitaxel to the first documentation of objective tumor progression. This TTP was to be only calculated for the subgroup of participants who were treated with the maintenance therapy. | Up to approximately 1 year |
| Trough PF-04136309 Concentrations [Phase 2] | The minimum plasma concentration of PF-04136309. | Cycle 1 Day 1 pre-dose, Cycle 1 Days 2, 8 and 15 pre-dose; Day 1 of Cycle 2 and subsequent cycles pre-dose, and EOT visit |
| Change From Baseline in Pharmacodynamic (PD) Markers in Metastatic Tumors and Bone Marrow [Phase 2] | Collections of core needle biopsy (CNB) from a metastatic site or fine-needle aspirate (FNA) from the primary tumor tissue were optional but at least 12 paired biopsies would have to be available and fully assessable in each treatment arm to allow the comparison. | Baseline, Cycle 1 Day 28 or Cycle 2 Day 28; EOT visit (optional) for CNB |
| Number of Participants With Peripheral Neurological Adverse Events [Phase 2] | To evaluate the improvement of peripheral neurotoxicity induced by nab-paclitaxel by the addition of PF-04136309 to the combination therapy of nab-paclitaxel plus gemcitabine. | Up to approximately 1 year |
| 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester Cancer Center Pharmacy | Rochester | New York | 14642 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Sampson Regional Medical Center | Clinton | North Carolina | 28328 | United States |
| Southeastern Medical Oncology Center | Clinton | North Carolina | 28328 | United States |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | United States |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | United States |
| Onslow Memorial Hospital | Jacksonville | North Carolina | 28546 | United States |
| Southeastern Medical Oncology Center | Jacksonville | North Carolina | 28546 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| MUSC Health East Cooper | Mt. Pleasant | South Carolina | 29464 | United States |
| MUSC Health North Charleston | North Charleston | South Carolina | 29406 | United States |
| To obtain contact information for a study center near you, click here. | View source |
| FG001 | Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. |
| FG002 | Phase 2: PF-04136309 or Placebo + Nab-paclitaxel + Gemcitabine | In Phase 2 part of the study which was not conducted due to early termination, participants were to be randomized with a 1:1 to receive either PF-04136309 or placebo in combination with nab-paclitaxel + gemcitabine. The dose of PF-04136309 was to be the recommended Phase 2 dose (RP2D) determined in the Phase 1b part of the study. |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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All Phase 1b enrolled participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. |
| BG001 | Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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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 (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b] | DLT: Any of the following events occurred in the first treatment cycle and was attributed to the combination of PF-04136309 with nab-paclitaxel and gemcitabine where relationship with the combination could not be ruled out. Hematologic: Grade (Gr) 4 neutropenia lasting more than (>)5 days; febrile neutropenia; Gr≥3 neutropenic infection; Gr≥3 thrombocytopenia with Gr≥2 bleeding; Gr4 thrombocytopenia. Non-Hematologic: Gr3 toxicities (except: nausea and vomiting responding to prophylaxis and/or treatment and lasting less than (<)7 days from each chemotherapy infusion period; diarrhea responding to treatment and lasting <7 days; Gr3 QTc prolongation [QTc >500 milliseconds] [a DLT only if persisting after correction of any reversible causes]; Gr3 aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) increase lasting less than or equal to (≤)7 days); all Gr4 toxicities; delay of >2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. | All Phase 1b enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Day 1 to Day 28 |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b] | An AE was any untoward medical occurrence in a participant who received study drug 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. | All Phase 1b enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 1 year |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b] | Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. | All Phase 1b enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 1 year |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b] | Following parameters were analyzed for hematology laboratory test: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell (WBC) count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | All Phase 1b enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 1 year |
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| Primary | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] | Following parameters were analyzed for chemistry laboratory test: blood urea nitrogen (BUN), creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, AST, ALT, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, Magnesium, phosphorous or phosphate. For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should have included albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time / international normalized ratio (PT/INR), alkaline phosphatase, total bile acids, and acetaminophen drug and/or protein adduct levels. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | All Phase 1b enrolled participants who received at least 1 dose of study treatment. GGT was an additional test for potential Hy's law. Only 1 participant in the PF-04136309 500 mg BID + Nab-paclitaxel + Gemcitabine treatment group was tested for GGT. | Posted | Count of Participants | Participants | 1 year |
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| Primary | Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] | Following parameters were analyzed for urinalysis laboratory test: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase), urine dipstick for urine protein (if positive collected 24 hour and microscopic [reflex testing]), urine dipstick for urine blood (if positive collected a microscopic [reflex testing]). Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. | All Phase 1b participants who received at least 1 dose of study treatment and had at least 1 post-dose urinalysis laboratory test. | Posted | Count of Participants | Participants | 1 year |
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| Primary | Progression Free Survival (PFS) [Phase 2] | PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. | No data to report as Phase 2 part was not conducted. | Posted | 1 year |
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| Secondary | PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Cmax of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | "Number of participants analyzed" represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmax data; "Number analyzed" represents the number of such participants for each category. | Posted | Number | nanograms per milliliter (ng/mL) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Cmax of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic coefficient of variation (CV) was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | "Number of participants analyzed" represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Tmax data; "Number analyzed" represents the number of such participants for each category. | Posted | Number | hours (hr) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Tmax data. | Posted | Median | Full Range | hours (hr) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | "Number of participants analyzed" represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had AUCtau data; "Number analyzed" represents the number of such participants for each category. | Posted | Number | nanogram*hour/milliliter (ng*hr/mL) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had AUCtau data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | Cmin of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | "Number of participants analyzed" represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmin data; "Number analyzed" represents the number of such participants for each category. | Posted | Number | ng/mL | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | Cmin of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmin data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] | CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. | "Number of participants analyzed" represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had CL/F data; "Number analyzed" represents the number of such participants for each category. | Posted | Number | Liters per hour (L/hr) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] | CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had CL/F data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour (L/hr) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b] | t1/2 was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had t1/2 data. | Posted | Mean | Standard Deviation | hours (hr) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b] | Vz/F was determined by Dose/(AUCtau×kel). AUCtau is the area under the curve from time 0 to end of dosing interval and kel is the terminal phase rate constant. | All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Vz/F data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15) |
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| Secondary | Ex Vivo Inhibition of Chemokine Ligand 2 (CCL2)-Induced Extracellular Signal Regulated Kinase (ERK) Phosphorylation in the Peripheral Blood [Phase 1b] | A drop in the CCL2-induced ERK kinase phosphorylation (pERK) biomarker level indicates target engagement (TE). | No data to report for this outcome measure as only individual plots were planned and generated to show the trend of biomarker level in each participant. Summary statistics were not planned and hence not generated. | Posted | Cycle 1 Day 1 pre-dose, 2 and 6 hours post-dose, and 12 hours (pre-second BID dose-optional collection); Cycle 1 Days 2, 3 and 4 pre-dose |
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| Other Pre-specified | Objective Response Rate (ORR) [Phase 1b] | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. | All the Phase 1b treated participants with measurable disease baseline assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 year |
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| Secondary | Number of Participants With Overall Survival (OS) [Phase 2] | OS was defined as the time from date of randomization to date of death due to any cause. For participants not expiring, their survival times were to be censored at the last date they were known to be alive. Participants lacking data beyond the day of randomization were to have their survival times censored at the date of randomization with duration of 1 day. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 13.5 months |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) [Phase 2] | An AE was any untoward medical occurrence in a participant administered a product or medical device 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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| Secondary | Number of Participants With Laboratory Abnormalities by Severity [Phase 2] | Hematology, chemistry, and urinalysis laboratory parameters were to be analyzed and graded by NCI CTCAE version 4.03. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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| Secondary | Objective Response Rate (ORR) [Phase 2] | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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| Secondary | Duration of Objective Response (DR) [Phase 2] | DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. DR data were to be censored on the day following the date of the last on treatment (including 28 day follow-up period after last dose) tumor assessment documenting absence of progressive disease for participants who did not have objective tumor progression and who did not die due to any cause while on treatment or who were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression. Participants who achieved a PR and then a CR were to have times calculated using the date of the PR as the first day. DR was only to be calculated for the subgroup of participants with objective response. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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| Secondary | Time to Progression (TTP) With the Double Combination PF-04136309 and Gemcitabine (Maintenance Therapy) After Interruption of Nab-paclitaxel [Phase 2] | This type of TTP was defined as the time from interruption of nab-paclitaxel to the first documentation of objective tumor progression. This TTP was to be only calculated for the subgroup of participants who were treated with the maintenance therapy. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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| Secondary | Trough PF-04136309 Concentrations [Phase 2] | The minimum plasma concentration of PF-04136309. | No data to report as Phase 2 part was not conducted. | Posted | Cycle 1 Day 1 pre-dose, Cycle 1 Days 2, 8 and 15 pre-dose; Day 1 of Cycle 2 and subsequent cycles pre-dose, and EOT visit |
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| Secondary | Change From Baseline in Pharmacodynamic (PD) Markers in Metastatic Tumors and Bone Marrow [Phase 2] | Collections of core needle biopsy (CNB) from a metastatic site or fine-needle aspirate (FNA) from the primary tumor tissue were optional but at least 12 paired biopsies would have to be available and fully assessable in each treatment arm to allow the comparison. | No data to report as Phase 2 part was not conducted. | Posted | Baseline, Cycle 1 Day 28 or Cycle 2 Day 28; EOT visit (optional) for CNB |
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| Secondary | Number of Participants With Peripheral Neurological Adverse Events [Phase 2] | To evaluate the improvement of peripheral neurotoxicity induced by nab-paclitaxel by the addition of PF-04136309 to the combination therapy of nab-paclitaxel plus gemcitabine. | No data to report as Phase 2 part was not conducted. | Posted | Up to approximately 1 year |
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AE data were collected from baseline through 28 days after last dose of study treatment (up to approximately 1 year).
Survival status was collected every 3 months after treatment discontinuation. A total of 11 deaths were reported, 1 of which was within AE reporting time frame (within 28 days after last dose of study treatment) and 10 of which were after AE reporting time frame (after 28 days following last dose of study treatment).
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 | Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. | 0 | 4 | 3 | 4 | 4 | 4 |
| EG001 | Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. | 11 | 17 | 11 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Episcleritis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oral mucosal eruption | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood albumin | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Immunoglobulins decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fine motor skill dysfunction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nail bed disorder | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Infarction | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
The study was terminated prematurely based on the company's change in prioritization for the portfolio and was not due to any safety concerns or regulatory interactions.
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 | Apr 8, 2016 | Aug 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000620181 | PF-04136309 |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| OG001 | Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine | PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles. |
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