Trial Outcomes & Findings for A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen (NCT NCT01094288)

Last Updated: 2019-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

From enrollment through 30 days after the last dose of study drug (approximately up to 77 months)

Results posted on

2019-02-15

Participant Flow

Participants took part in the study at 4 investigative sites in the United States from 17 August 2010 to 04 January 2017.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	6	15	5	3	2	4	2	4
Overall Study COMPLETED	4	5	1	1	2	4	2	2
Overall Study NOT COMPLETED	2	10	4	2	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Overall Study Adverse Event	0	3	1	1	0
Overall Study Withdrawal by Subject	0	1	2	0	2
Overall Study Initiation of Alternative Therapy	0	0	1	0	0
Overall Study Reason not Specified	2	3	0	1	0
Overall Study Ongoing Participants	0	3	0	0	0

Baseline Characteristics

A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 5.20 • n=5 Participants	61.5 years STANDARD_DEVIATION 13.10 • n=7 Participants	60.2 years STANDARD_DEVIATION 16.75 • n=5 Participants	61.3 years STANDARD_DEVIATION 8.62 • n=4 Participants	56.5 years STANDARD_DEVIATION 2.12 • n=21 Participants	54.8 years STANDARD_DEVIATION 18.73 • n=10 Participants	52.5 years STANDARD_DEVIATION 26.16 • n=115 Participants	62.3 years STANDARD_DEVIATION 25.71 • n=24 Participants	60.4 years STANDARD_DEVIATION 14.07 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	11 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	30 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	5 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	1 participants n=115 Participants	0 participants n=24 Participants	7 participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 participants n=5 Participants	10 participants n=7 Participants	5 participants n=5 Participants	3 participants n=4 Participants	1 participants n=21 Participants	3 participants n=10 Participants	1 participants n=115 Participants	4 participants n=24 Participants	33 participants n=42 Participants
Race/Ethnicity, Customized Not Reported	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	0 participants n=24 Participants	1 participants n=42 Participants
Race/Ethnicity, Customized White	6 participants n=5 Participants	15 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	3 participants n=10 Participants	2 participants n=115 Participants	3 participants n=24 Participants	38 participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	0 participants n=115 Participants	1 participants n=24 Participants	2 participants n=42 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants	0 participants n=24 Participants	1 participants n=42 Participants
Region of Enrollment United States	6 participants n=5 Participants	15 participants n=7 Participants	5 participants n=5 Participants	3 participants n=4 Participants	2 participants n=21 Participants	4 participants n=10 Participants	2 participants n=115 Participants	4 participants n=24 Participants	41 participants n=42 Participants
Height	185.5 cm STANDARD_DEVIATION 11.02 • n=5 Participants	170.5 cm STANDARD_DEVIATION 10.04 • n=7 Participants	177.2 cm STANDARD_DEVIATION 12.13 • n=5 Participants	171.0 cm STANDARD_DEVIATION 10.08 • n=4 Participants	174.5 cm STANDARD_DEVIATION 0.71 • n=21 Participants	172.5 cm STANDARD_DEVIATION 10.98 • n=10 Participants	155.6 cm STANDARD_DEVIATION 8.08 • n=115 Participants	174.9 cm STANDARD_DEVIATION 6.99 • n=24 Participants	173.6 cm STANDARD_DEVIATION 11.32 • n=42 Participants
Weight	100.25 kg STANDARD_DEVIATION 15.842 • n=5 Participants	82.73 kg STANDARD_DEVIATION 16.963 • n=7 Participants	94.15 kg STANDARD_DEVIATION 25.623 • n=5 Participants	87.73 kg STANDARD_DEVIATION 31.987 • n=4 Participants	76.90 kg STANDARD_DEVIATION 8.344 • n=21 Participants	85.97 kg STANDARD_DEVIATION 15.987 • n=10 Participants	62.05 kg STANDARD_DEVIATION 11.950 • n=115 Participants	87.05 kg STANDARD_DEVIATION 21.025 • n=24 Participants	86.50 kg STANDARD_DEVIATION 19.550 • n=42 Participants
Body Surface Area (BSA)	2.269 m^2 STANDARD_DEVIATION 0.2329 • n=5 Participants	1.973 m^2 STANDARD_DEVIATION 0.2533 • n=7 Participants	2.138 m^2 STANDARD_DEVIATION 0.3541 • n=5 Participants	2.025 m^2 STANDARD_DEVIATION 0.4316 • n=4 Participants	1.929 m^2 STANDARD_DEVIATION 0.1009 • n=21 Participants	2.026 m^2 STANDARD_DEVIATION 0.2420 • n=10 Participants	1.635 m^2 STANDARD_DEVIATION 0.2005 • n=115 Participants	2.046 m^2 STANDARD_DEVIATION 0.2945 • n=24 Participants	2.034 m^2 STANDARD_DEVIATION 0.2878 • n=42 Participants

PRIMARY outcome

Timeframe: From enrollment through 30 days after the last dose of study drug (approximately up to 77 months)

Population: Safety Population included all participants who received at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 participants	15 participants	5 participants	3 participants	2 participants	4 participants	2 participants	4 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	3 participants	8 participants	3 participants	2 participants	1 participants	3 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2

Population: 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.

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.
Cmax: Maximum Observed Plasma Concentration for Docetaxel Cycle 2 Day 1	1825.1 ng/mL Geometric Coefficient of Variation 25.9	1957.0 ng/mL Geometric Coefficient of Variation 23.4	2146.6 ng/mL Geometric Coefficient of Variation 19.4	3299.9 ng/mL Geometric Coefficient of Variation 0.9	1649.7 ng/mL Geometric Coefficient of Variation 19.1	1061.6 ng/mL Geometric Coefficient of Variation 24.8	2504.6 ng/mL Geometric Coefficient of Variation 28.0	1627.8 ng/mL Geometric Coefficient of Variation 17.2
Cmax: Maximum Observed Plasma Concentration for Docetaxel Cycle 1 Day 1	2392.7 ng/mL Geometric Coefficient of Variation 60.2	1730.4 ng/mL Geometric Coefficient of Variation 26.5	1587.0 ng/mL Geometric Coefficient of Variation 34.1	1717.6 ng/mL Geometric Coefficient of Variation 51.9	3751.4 ng/mL Geometric Coefficient of Variation 80.8	1159.9 ng/mL Geometric Coefficient of Variation 13.8	2232.9 ng/mL Geometric Coefficient of Variation 19.8	1386.6 ng/mL Geometric Coefficient of Variation 47.0

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2

Population: 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.

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel Cycle 1 Day 1	2328.3 hr*ng/mL Geometric Coefficient of Variation 69.5	1925.7 hr*ng/mL Geometric Coefficient of Variation 21.4	1750.1 hr*ng/mL Geometric Coefficient of Variation 23.1	2163.4 hr*ng/mL Geometric Coefficient of Variation 52.8	1830.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation is not estimable as only 1 participants is assessed.	1593.1 hr*ng/mL Geometric Coefficient of Variation 14.0	2394.6 hr*ng/mL Geometric Coefficient of Variation 2.7	1579.8 hr*ng/mL Geometric Coefficient of Variation 45.4
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel Cycle 2 Day 1	1750.8 hr*ng/mL Geometric Coefficient of Variation 23.1	2416.4 hr*ng/mL Geometric Coefficient of Variation 23.7	25.5 hr*ng/mL Geometric Coefficient of Variation 2174.6	7811.5 hr*ng/mL Geometric Coefficient of Variation 87.5	1622.8 hr*ng/mL Geometric Coefficient of Variation 35.0	1596.0 hr*ng/mL Geometric Coefficient of Variation 19.9	2895.7 hr*ng/mL Geometric Coefficient of Variation 16.3	2510.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation is not estimable as only 1 participants is assessed.

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity for Docetaxel Cycle 1 Day 1	2653.3 hr*ng/mL Geometric Coefficient of Variation 68.1	2240.6 hr*ng/mL Geometric Coefficient of Variation 23.9	2007.3 hr*ng/mL Geometric Coefficient of Variation 15.7	3570.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation is not estimable as only 1 participants is assessed.	2130.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation is not estimable as only 1 participants is assessed.	1734.7 hr*ng/mL Geometric Coefficient of Variation 9.6	2600.0 hr*ng/mL Geometric Coefficient of Variation 0.0	1730.9 hr*ng/mL Geometric Coefficient of Variation 53.9
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity for Docetaxel Cycle 2 Day 1	1918.0 hr*ng/mL Geometric Coefficient of Variation 21.4	2632.2 hr*ng/mL Geometric Coefficient of Variation 28.0	2019.8 hr*ng/mL Geometric Coefficient of Variation 10.1	4000.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation is not estimable as only 1 participants is assessed.	1785.4 hr*ng/mL Geometric Coefficient of Variation 35.6	1631.0 hr*ng/mL Geometric Coefficient of Variation 9.9	3099.0 hr*ng/mL Geometric Coefficient of Variation 14.3	3120.0 hr*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation is not estimable as only 1 participants is assessed.

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=5 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=3 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 60 mg/m^2 n=2 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 60 mg/m^2 n=4 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=2 Participants 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.	Alisertib 40 mg (5D) + Docetaxel 75 mg/m^2 + GCSF n=4 Participants 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.
Terminal Phase Elimination Half-life (T1/2) for Docetaxel Cycle 1 Day 1	21.80 hr Standard Deviation 4.339	22.88 hr Standard Deviation 4.733	24.00 hr Standard Deviation 6.934	15.60 hr Standard Deviation NA Standard deviation is not estimable as only 1 participants is assessed.	30.70 hr Standard Deviation NA Standard deviation is not estimable as only 1 participants is assessed.	16.34 hr Standard Deviation 5.684	19.25 hr Standard Deviation 2.051	24.80 hr Standard Deviation 6.444
Terminal Phase Elimination Half-life (T1/2) for Docetaxel Cycle 2 Day 1	24.18 hr Standard Deviation 2.050	20.73 hr Standard Deviation 5.845	20.40 hr Standard Deviation 2.121	16.40 hr Standard Deviation NA Standard deviation is not estimable as only 1 participants is assessed.	25.10 hr Standard Deviation 2.546	22.00 hr Standard Deviation 2.404	16.95 hr Standard Deviation 0.636	26.00 hr Standard Deviation NA Standard deviation is not estimable as only 1 participants is assessed.

SECONDARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=16 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=4 Participants 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.	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.	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.	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.	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.
Cmax: Maximum Observed Plasma Concentration for Alisertib Cycle 1 Day 1	290.4 nmol/L Geometric Coefficient of Variation 22.1	557.5 nmol/L Geometric Coefficient of Variation 57.3	751.6 nmol/L Geometric Coefficient of Variation 31.3	1346.4 nmol/L Geometric Coefficient of Variation 49.8	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for Alisertib Cycle 1 Day 5/Day 7	435.8 nmol/L Geometric Coefficient of Variation 31.0	1140.6 nmol/L Geometric Coefficient of Variation 44.7	1637.9 nmol/L Geometric Coefficient of Variation 52.1	1766.3 nmol/L Geometric Coefficient of Variation 40.1	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Alisertib 10 mg (7D) + Docetaxel 75 mg/m^2 n=6 Participants 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.	Alisertib 20 mg (7D) + Docetaxel 75 mg/m^2 n=15 Participants 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.	Alisertib 30 mg (7D) + Docetaxel 75 mg/m^2 n=26 Participants 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.	Alisertib 30 mg (5D) + Docetaxel 75 mg/m^2 n=4 Participants 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.	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.	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.	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.	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.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib Cycle 1 Day 5/Day 7	3.510 hr Interval 1.87 to 8.22	3.030 hr Interval 2.0 to 9.4	2.030 hr Interval 2.0 to 8.0	1.975 hr Interval 1.08 to 3.0	—	—	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib Cycle 1 Day 1	2.050 hr Interval 2.0 to 3.0	4.000 hr Interval 2.0 to 9.98	3.560 hr Interval 2.0 to 12.0	1.500 hr Interval 1.0 to 7.58	—	—	—	—

SECONDARY outcome

Timeframe: 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