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| ID | Type | Description | Link |
|---|---|---|---|
| 1015004128 | Registry Identifier | TCTIN | |
| U1111-1187-6744 | Registry Identifier | WHO |
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The purpose of this study was to determine the safety profile, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to characterize the pharmacokinetic (PK) profile of alisertib twice daily (BID) dosing for 7 days in East Asian participants with advanced solid tumors or lymphomas. The secondary objective was to describe any antitumor activity that may have been observed with alisertib treatment.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors or lymphomas for which standard curative or life-prolonging treatment did not exist or was no longer effective or tolerable. This study evaluated the safety and pharmacokinetic (PK) profile, and maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of alisertib, as well as any antitumor activity.
The study enrolled 36 patients. Participants were assigned to one of the two treatment groups and received:
This multi-center trial is conducted in East Asia. The overall time to participate in this study was 24 months, unless it was determined that a participant would derive benefit from continued therapy beyond 24 months. Participants made multiple visits to the clinic, and were contacted up to a maximum of 30 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib 30 mg | Experimental | Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
|
| Alisertib 40 mg | Experimental | Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib enteric-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) | MTD was defined as highest dose at which <2 participants experienced a dose-limiting toxicity (DLT). DLT was defined as any of the following events considered possibly related to therapy with alisertib by the investigator: 1. Grade 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >7 days; 2. Grade 4 neutropenia with fever (oral or ear temperature ≥38.5°C); 3. Grade 4 thrombocytopenia (platelets <25,000/mm^3) for >7 days; 4. Platelet count <10,000 cells/mm^3; 5. ≥Grade 3 thrombocytopenia with clinically significant bleeding; 6. Delay in initiation of subsequent cycle by >7 days due to treatment-related toxicity; 7. ≥Grade 3 nonhematological toxicity except following: a. ≥Grade 3 nausea and/or emesis in the absence of optimal antiemetic therapy; b. ≥Grade 3 diarrhea in the absence of optimal supportive therapy; c. Grade 3 fatigue lasting <1 week; d. Other Grade 3 nonhematological toxicity that can be safely and reliably controlled to ≤Grade 2 with appropriate treatment. | Treatment Cycle 1 |
| Number of Participants With Adverse Events and Serious Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | First dose to 30 days past last dose (Up to 12.1 Months) |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as Adverse Events | Laboratory AEs in the following system organ classes (SOCs) are reported: blood and lymphatic system disorders, investigations, and metabolism and nutrition disorders. An abnormal laboratory value was assessed as an AE if that value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment¬-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate Based on Investigator Assessment | Best overall response rate is defined as the percentage of participants with complete response (CR) and/or partial response (PR) as assessed by the Investigator using Lymphoma International Working Group (IWG) Criteria or Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT, PET or MRI. IWG criteria for CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. RECIST response criteria is defined as: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre | Tiong Bahru | 169610 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26084989 | Derived | Venkatakrishnan K, Kim TM, Lin CC, Thye LS, Chng WJ, Ma B, Chen MH, Zhou X, Liu H, Kelly V, Kim WS. Phase 1 study of the investigational Aurora A kinase inhibitor alisertib (MLN8237) in East Asian cancer patients: pharmacokinetics and recommended phase 2 dose. Invest New Drugs. 2015 Aug;33(4):942-53. doi: 10.1007/s10637-015-0258-y. Epub 2015 Jun 19. |
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Participants with a diagnosis of advanced solid tumors or lymphomas received alisertib 30 mg or 40 mg twice a day (BID) for 7 consecutive days followed by a 14-day rest period in 21-day cycles (28-day cycles with additional 7-day rest period if all alisertib-related toxicities [except alopecia] were not resolved to less than Grade 2).
Participants took part in the study at 8 investigative sites in Singapore, Taiwan, Hong Kong, and South Korea from 06 February 2012 to 08 October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib 30 mg | Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
| FG001 | Alisertib 40 mg | Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population is defined as all participants who received at least one dose of alisertib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib 30 mg | Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) | MTD was defined as highest dose at which <2 participants experienced a dose-limiting toxicity (DLT). DLT was defined as any of the following events considered possibly related to therapy with alisertib by the investigator: 1. Grade 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >7 days; 2. Grade 4 neutropenia with fever (oral or ear temperature ≥38.5°C); 3. Grade 4 thrombocytopenia (platelets <25,000/mm^3) for >7 days; 4. Platelet count <10,000 cells/mm^3; 5. ≥Grade 3 thrombocytopenia with clinically significant bleeding; 6. Delay in initiation of subsequent cycle by >7 days due to treatment-related toxicity; 7. ≥Grade 3 nonhematological toxicity except following: a. ≥Grade 3 nausea and/or emesis in the absence of optimal antiemetic therapy; b. ≥Grade 3 diarrhea in the absence of optimal supportive therapy; c. Grade 3 fatigue lasting <1 week; d. Other Grade 3 nonhematological toxicity that can be safely and reliably controlled to ≤Grade 2 with appropriate treatment. | DLT-Evaluable population is defined as participants with a common race who had not used granulocyte colony-stimulating factor (G-CSF) in cycle 1, and either experienced DLT during Cycle 1 or received at least 85% of planned doses of alisertib and have sufficient follow up data to allow investigator and sponsor to determine whether a DLT occurred. | Posted | Number | mg | Treatment Cycle 1 |
First dose to 30 days past last dose (Up to 12.1 Months)
At each visit the Investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alisertib 30 mg | Alisertib 30 mg enteric-coated tablets (ECT), orally, twice a day (BID) for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 16 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C550258 | MLN 8237 |
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| First dose to 30 days past last dose (Up to 12.1 Months) |
| Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Events | Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study. | First dose to 30 days past last dose (Up to 12.1 Months) |
| Cmax: Maximum Observed Concentration for Alisertib | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
| Tmax: Time to First Occurrence of Cmax for Alisertib | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
| AUCτ: Area Under the Concentration-Time Curve From Time 0 to End of Dosing Interval (τ) for Alisertib | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
| Dose Normalized AUCτ: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib | Dose normalized AUCτ was obtained using AUCτ divided by alisertib dose in milligrams. | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
| T1/2: Terminal Half-Life for Alisertib | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
| Rac: Accumulation Ratio for Alisertib | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
| PTR: Peak Trough Ratio During a Dosing Interval, at Steady State for Alisertib | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
| CLss/F: Apparent Clearance After Extravascular Administration, at Steady State, Calculated Using AUCτ for Alisertib | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
| Baseline and every 2 cycles for up to 24 months or until progressive disease |
| Duration of Response | DOR is defined as the time from the date of first documentation of a CR response to the date of first documentation of PD according to IWG criteria or RECIST criteria 1.1. IWG PD is defined as PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. RECIST PD is defined as unequivocal progression of existing non-target lesions. | First documented response until disease progression; approximately 12 months |
| Concentrations of Relevant Tumor Markers | Cycle 1, Day 1; at end of Cycle 2 and every 2 cycles thereafter; and at end treatment; approximately 12 months |
| BG001 | Alisertib 40 mg | Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Surface Area (BSA) | BSA = square root [height (cm) x weight (kg)/3600] | Mean | Standard Deviation | m^2 |
|
|
|
|
| Primary | Number of Participants With Adverse Events and Serious Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety Population is defined as all participants who received at least one dose of alisertib. | Posted | Count of Participants | Participants | First dose to 30 days past last dose (Up to 12.1 Months) |
|
|
|
| Primary | Number of Participants With Abnormal Clinical Laboratory Values Reported as Adverse Events | Laboratory AEs in the following system organ classes (SOCs) are reported: blood and lymphatic system disorders, investigations, and metabolism and nutrition disorders. An abnormal laboratory value was assessed as an AE if that value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment¬-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population is defined as all participants who received at least one dose of alisertib. | Posted | Count of Participants | Participants | First dose to 30 days past last dose (Up to 12.1 Months) |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Events | Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study. | Safety Population is defined as all participants who received at least one dose of alisertib. | Posted | Count of Participants | Participants | First dose to 30 days past last dose (Up to 12.1 Months) |
|
|
|
| Primary | Cmax: Maximum Observed Concentration for Alisertib | Pharmacokinetic (PK) Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | nM | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | Tmax: Time to First Occurrence of Cmax for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. "n" in the category is the number of participants with data available at the given time-point. | Posted | Median | Full Range | hr | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | AUCτ: Area Under the Concentration-Time Curve From Time 0 to End of Dosing Interval (τ) for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | nM*hr | Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | Dose Normalized AUCτ: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib | Dose normalized AUCτ was obtained using AUCτ divided by alisertib dose in milligrams. | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. | Posted | Mean | Standard Deviation | nM*hr/mg | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | T1/2: Terminal Half-Life for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. | Posted | Mean | Standard Deviation | hr | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | Rac: Accumulation Ratio for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. | Posted | Mean | Standard Deviation | ratio | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | PTR: Peak Trough Ratio During a Dosing Interval, at Steady State for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. | Posted | Mean | Standard Deviation | ratio | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Primary | CLss/F: Apparent Clearance After Extravascular Administration, at Steady State, Calculated Using AUCτ for Alisertib | PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. | Posted | Mean | Standard Deviation | L/hr | Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose |
|
|
|
| Secondary | Best Overall Response Rate Based on Investigator Assessment | Best overall response rate is defined as the percentage of participants with complete response (CR) and/or partial response (PR) as assessed by the Investigator using Lymphoma International Working Group (IWG) Criteria or Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT, PET or MRI. IWG criteria for CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. RECIST response criteria is defined as: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. | Safety Population is defined as all participants who received at least one dose of alisertib. | Posted | Number | percentage of participants | Baseline and every 2 cycles for up to 24 months or until progressive disease |
|
|
|
| Secondary | Duration of Response | DOR is defined as the time from the date of first documentation of a CR response to the date of first documentation of PD according to IWG criteria or RECIST criteria 1.1. IWG PD is defined as PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. RECIST PD is defined as unequivocal progression of existing non-target lesions. | Safety Population is defined as all participants who received at least one dose of alisertib. Participants with response were evaluated. | Posted | Median | Full Range | days | First documented response until disease progression; approximately 12 months |
|
|
|
| Secondary | Concentrations of Relevant Tumor Markers | Data was not analyzed as per the change in planned analysis (protocol amendment). | Posted | Cycle 1, Day 1; at end of Cycle 2 and every 2 cycles thereafter; and at end treatment; approximately 12 months |
|
|
| 15 |
| 30 |
| 30 |
| 30 |
| EG001 | Alisertib 40 mg | Alisertib 40 mg ECT, orally, BID for 7 days, followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable alisertib-related toxicities (up to 7 cycles). Cycles could be extended to 28-day cycles (with additional 7-day rest period) if all alisertib-related toxicities (except alopecia) were not resolved to less than Grade 2. | 4 | 6 | 6 | 6 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lower extremity mass | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment | One treatment-emergent death occurred during treatment with alisertib 30 mg and was not related. |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Thrombocytopenia |
|
| Febrile neutropenia |
|
| Leukopenia |
|
| White blood cell count decreased |
|
| Aspartate aminotransferase increased |
|
| Neutrophil count decreased |
|
| Alanine aminotransferase increased |
|
| Platelet count decreased |
|
| Blood bilirubin increased |
|
| Haemoglobin decreased |
|
| Blood creatinine increased |
|
| Urine output decreased |
|
| Hypokalaemia |
|
| Hypercalcaemia |
|
| Hyponatraemia |
|
| Bradycardia |
|
| Pyrexia |
|
| Day 7 |
|
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| Day 7 |
|
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| Day 7 |
|
|