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The purpose of this study is to evaluate the safety and tolerability of alisertib in combination with docetaxel as a treatment for participants with advanced solid tumors, including castration-resistant prostate cancer, who were deemed by the investigator to be medically appropriate candidates for docetaxel therapy.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors including castration-resistant prostate cancer.
The study enrolled approximately 41 patients. Participants were enrolled to receive:
• Alisertib 10-40 mg + docetaxel 60-75 mg/m^2
All participants will receive alisertib (ECT) in dose escalating cohorts, orally, twice daily for 7 days followed by 14-day rest period in Cycle 1, 3 and onwards (21-day cycle) and orally twice daily from Day 3 to Day 7 followed by 14 day rest period in Cycle 2 [dose held for pharmacokinetic (PK) collection] along with docetaxel 75 mg/m^2, intravenous (IV) infusion on Day 1 of each cycle for maximum of 12 months, or until the occurrence of progressive disease (PD), unmanageable AEs or withdrawal of consent.
This multi-center trial is conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. Participants made multiple visits to the clinic, and were contacted every 12 weeks for up to 25.8 months after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib + Docetaxel | Experimental | Alisertib in escalating dose (10-40 mg), enteric-coated tablets (ECT), orally, twice daily for 7 days followed by 14-day rest period in Cycle 1, 3 and onwards (21-day cycle) and orally twice daily from Day 3 to Day 7 followed by 14 day rest period in Cycle 2 along with docetaxel 60-75 mg/m^2, intravenous (IV) infusion on Day 1 of each cycle for maximum of 12 months, or until the occurrence of progressive disease (PD), unmanageable adverse events (AEs) or withdrawal of consent. The starting alisertib dose is 10 mg, orally, twice daily (total 20 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib ECT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE 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. | From enrollment through 30 days after the last dose of study drug (approximately up to 77 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Docetaxel | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 | |
| AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel |
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Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
18 years or older
Histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment
Measurable or evaluable disease is required. Participants must have clinical evidence of progressive disease or persistent disease
Participants with castration-resistant prostate cancer (CRPC) are required to have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Recovered to less than or equal to Grade 1 toxicity (CTCAE), to participant's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease
Adequate bone marrow, liver and renal function
Any use of opiates must be stable for at least 2 weeks prior to study entry
Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time
Male participants who agree to practice effective barrier contraception during the entire study and through 6 months after the last dose of study drug OR agree to abstain from heterosexual intercourse
Voluntary written consent
Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Suitable venous access for blood sampling
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Female participants who are lactating or pregnant
Antineoplastic therapy or any experimental therapy within 21 days before the first dose of alisertib
Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
Concurrent investigational treatment of treatment with any investigational products within 28 days before the first dose of alisertib
Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor
Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.
Autologous stem cell transplant within 3 months before the first dose of alisetib, or prior allogeneic stem cell transplant at any time.
Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib
For CRPC participants:
Major surgery within 4 weeks of study enrollment
Uncontrolled high blood pressure
Participants with abnormal gastric or bowel function or who require continuous treatment with antacids or proton pump inhibitors
Participants receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone
Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
Comorbid condition or unresolved toxicity that would preclude administration of docetaxel
Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not resolved to Grade 1 or below
Symptomatic brain or other CNS metastasis
Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
Participants requiring full systemic anticoagulation
Prior allogeneic bone marrow or other organ transplant
Active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection
History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
Serious medical or psychiatric illness that could interfere with protocol completion
Inability to swallow oral medication
Prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Prior treatment with more than 1 prior taxane-containing regimen
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | United States | ||||
Participants with a diagnosis of Advanced solid tumors, including castration-resistant prostate cancer were enrolled to receive alisertib Alisertib 10-40 mg + docetaxel 60-75 mg/m^2 intravenous (IV) infusion and granulocyte colony stimulating factor (GCSF) in escalating dose cohorts.
Participants took part in the study at 4 investigative sites in the United States from 17 August 2010 to 04 January 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Docetaxel | Drug | Docetaxel IV infusion |
|
| Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
| AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity for Docetaxel | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
| Terminal Phase Elimination Half-life (T1/2) for Docetaxel | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
| Cmax: Maximum Observed Plasma Concentration for Alisertib | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
| AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Day 7 Over the Dosing Interval for Alisertib | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
| Overall Response Rate (ORR) Assessed for Overall Participant Population | ORR is defined as percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by response evaluation criteria in solid tumors (RECIST) v 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of longest diameter (LD) of target lesions in reference to Baseline. RECIST-Evaluable Population is subset of safety population who had measurable disease by RECIST v 1.1 at baseline and had at least 1 post baseline response. prostate specific antigen (PSA)-Evaluable Population is subset of the safety population who had a baseline PSA reference value (>5 ng/mL) and at least 12 weeks post-baseline PSA assessment for participants with no decline from baseline, or PSA progression within 12 weeks of treatment for participants with PSA decline from baseline. | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Overall Response Rate for Prostate Cancer Participants | ORR is defined as percentage of participants who achieved CR or PR as assessed by either RECIST v 1.1 or PSA response by prostate cancer working group 2 (PCWG2) criteria. According to RECIST v 1.1, CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. PSA response by PCWG2 is defined as PSA at least 50% decrease in PSA value from baseline for 2 consecutive evaluations. PCWG2 defines PSA progression as the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Best Overall Response Rate Assessed by RECIST Criteria | Best response rate is defined as the percentage of participants with CR, PR, CR+PR, stable disease (SD) and progressive disease (PD) as assessed by RECIST criteria 1.1 for target lesions and assessed by CT, PET or MRI. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Best Overall Response Rate Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria | Best Response Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria PSA response is defined as at least 50% decrease in PSA value from baseline for 2 consecutive evaluations. | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Duration of Response | Duration of response is defined as the time from the date of first documentation of a response to the date of first documented progressive disease (PD), or censored at last SD or better. | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Duration of Stable Disease (SD) | Duration of SD is defined as the time from first dose to first PD, or censored at last SD or better. | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| Portland |
| Oregon |
| United States |
| San Antonio | Texas | United States |
| Seattle | Washington | United States |
| FG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| FG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population included all participants who received at least 1 dose of any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent. |
| BG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Surface Area (BSA) | BSA (m^2) = square root [height (cm) * weight (kg)/3600]. | Mean | Standard Deviation | m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE 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 included all participants who received at least 1 dose of any study drug. | Posted | Number | participants | From enrollment through 30 days after the last dose of study drug (approximately up to 77 months) |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for Docetaxel | Pharmacokinetic (PK) parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
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| Secondary | AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
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| Secondary | AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity for Docetaxel | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
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| Secondary | Terminal Phase Elimination Half-life (T1/2) for Docetaxel | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Mean | Standard Deviation | hr | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2 |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for Alisertib | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
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| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Median | Full Range | hr | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
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| Secondary | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Day 7 Over the Dosing Interval for Alisertib | PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nmol/L | Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1 |
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| Secondary | Overall Response Rate (ORR) Assessed for Overall Participant Population | ORR is defined as percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by response evaluation criteria in solid tumors (RECIST) v 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of longest diameter (LD) of target lesions in reference to Baseline. RECIST-Evaluable Population is subset of safety population who had measurable disease by RECIST v 1.1 at baseline and had at least 1 post baseline response. prostate specific antigen (PSA)-Evaluable Population is subset of the safety population who had a baseline PSA reference value (>5 ng/mL) and at least 12 weeks post-baseline PSA assessment for participants with no decline from baseline, or PSA progression within 12 weeks of treatment for participants with PSA decline from baseline. | Response-Evaluable Population included participants who were either RECIST evaluable and/or PSA-evaluable. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
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| Secondary | Overall Response Rate for Prostate Cancer Participants | ORR is defined as percentage of participants who achieved CR or PR as assessed by either RECIST v 1.1 or PSA response by prostate cancer working group 2 (PCWG2) criteria. According to RECIST v 1.1, CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. PSA response by PCWG2 is defined as PSA at least 50% decrease in PSA value from baseline for 2 consecutive evaluations. PCWG2 defines PSA progression as the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. | Response-Evaluable Population included participants who were either RECIST evaluable or PSA-evaluable. Here, number of participants analyzed are the enrolled participants who had castration-resistant prostate cancer (CRPC) and were evaluable by either RECIST or PSA response criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
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| Secondary | Best Overall Response Rate Assessed by RECIST Criteria | Best response rate is defined as the percentage of participants with CR, PR, CR+PR, stable disease (SD) and progressive disease (PD) as assessed by RECIST criteria 1.1 for target lesions and assessed by CT, PET or MRI. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | RECIST-Evaluable Population included a subset of the safety population who had measurable disease by RECIST v 1.1 at baseline and had at least 1 post baseline response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
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| Secondary | Best Overall Response Rate Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria | Best Response Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria PSA response is defined as at least 50% decrease in PSA value from baseline for 2 consecutive evaluations. | PSA-Evaluable Population is a subset of the safety population who had a baseline PSA reference value (>5 ng/mL) and at least 12 weeks post-baseline PSA assessment for participants with no decline from baseline, or PSA progression within 12 weeks of treatment for participants with PSA decline from baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response is defined as the time from the date of first documentation of a response to the date of first documented progressive disease (PD), or censored at last SD or better. | Response-Evaluable population includes patients that are either RECIST-evaluable or PSA-evaluable. Here, number of participants analyzed are the participants who were responders. A responder that did not experience disease progression were censored at the last response assessment that is SD or better. | Posted | Median | Full Range | days | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease (SD) | Duration of SD is defined as the time from first dose to first PD, or censored at last SD or better. | Response-Evaluable population includes patients that are either RECIST-evaluable or PSA-evaluable. Here, number of participants analyzed are the participants who had SD. For a participants that has not progressed, duration of SD is censored at the last response assessment that is SD or better. | Posted | Median | Full Range | days | Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months) |
|
From signing of the informed consent form up to 30 days after the last dose of study drug (up to 25.8 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.
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 | Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 10 mg, enteric-coated tablets (ECT), orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 28 cycles, or until the occurrence of PD, unmanageable adverse events (AEs) or withdrawal of consent. | 3 | 6 | 6 | 6 | ||
| EG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 10 | 15 | 14 | 15 | ||
| EG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 3 | 5 | 5 | 5 | ||
| EG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 2 | 3 | 3 | 3 | ||
| EG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 1 | 2 | 2 | 2 | ||
| EG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 3 | 4 | 4 | 4 | ||
| EG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 2 | 2 | 2 | 2 | ||
| EG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. | 2 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment | One treatment-emergent death occurred during treatment with MLN8237 20 mg + Docetaxel 75 mg/m^2 and is not related to treatment. |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment | One treatment-emergent death occurred during treatment with MLN8237 30 mg (5D) + Docetaxel 75 mg/m^2 and is not related to treatment. |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment | One treatment-emergent death occurred during treatment with MLN8237 30 mg (5D) + Docetaxel 75 mg/m^2 and is not related to treatment. |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rectal discharge | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Urine cytology abnormal | Investigations | MedDRA version 8.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Stoma site pain | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA version 8.1 | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA version 8.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| C550258 | MLN 8237 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Black or African American |
|
| Other |
|
| SAEs |
|
| OG002 |
| Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 |
Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| OG002 |
| Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 |
Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 |
Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| Alisertib 40 mg |
Alisertib 40 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2. Assessment was performed on Day 5 if alisertib was given on a 5 day schedule. |
|
|
| Alisertib 40 mg |
Alisertib 40 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2. Assessment was performed on Day 5 if alisertib was given on a 5 day schedule. |
|
|
| OG003 |
| Alisertib 40 mg |
Alisertib 40 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2. Assessment was performed on Day 5 if alisertib was given on a 5 day schedule. |
|
|
| OG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| OG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| OG001 | Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 20 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 34 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
|
|
| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
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| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
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| OG002 | Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 36 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG003 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 17 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG004 | Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 7 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 15 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG005 | Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 60 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG006 | Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 30 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 2 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
| OG007 | Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF | Alisertib 40 mg, ECT, orally, twice daily for 5 days in Cycle 1, 3 and onwards; and orally twice daily from Day 3 to Day 7 in Cycle 2 followed by 14 day rest period along with docetaxel 75 mg/m^2, intravenous infusion on Day 1 of each cycle (21-day cycle) and granulocyte colony stimulating factor (GCSF) as per standard of care for a maximum of 5 cycles, or until the occurrence of PD, unmanageable AEs or withdrawal of consent. |
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