Trial Outcomes & Findings for Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients (NCT NCT02091531)

NCT ID: NCT02091531

Last Updated: 2019-11-21

Results Overview

from the start of treatment, as defined by the Prostate Cancer Working Group 2 (PCWG2) guidelines.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Up to 8 months
• Results posted on: 2019-11-21

Participant Flow

Participant milestones

Measure	MLN0128 Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients

Baseline characteristics by cohort

Measure	MLN0128 n=9 Participants Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 months

from the start of treatment, as defined by the Prostate Cancer Working Group 2 (PCWG2) guidelines.

Outcome measures

Measure	MLN0128 n=9 Participants Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Median Time on Treatment	11 weeks Interval 3.0 to 30.0

SECONDARY outcome

Timeframe: Duration of Treatment, up to 30 weeks

Summary tables and waterfall plots describing change in PSA relative to baseline will be reported at end of treatment

Outcome measures

Measure	MLN0128 n=9 Participants Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Median PSA Rise at End of Treatment as Compared to Baseline	159 percentage PSA increase from basline Interval 12.0 to 620.0

SECONDARY outcome

Timeframe: Duration of Treatment, up to 30 weeks

We propose to study both FDG and optional FDHT PET imaging at baseline, 4 weeks after treatment initiation and at the time of progression (end-of-treatment), and to correlate the changes with treatment response. Response and progression will be evaluated in this study using a combination of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee and modified for prostate cancer and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2).21

Outcome measures

Measure	MLN0128 n=9 Participants Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Best Response Stable Disease	8 Participants
Best Response Progression of Disease	1 Participants

Adverse Events

MLN0128

Serious events: 6 serious events

Other events: 9 other events

Deaths: 9 deaths

Serious adverse events

Measure	MLN0128 n=9 participants at risk Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Immune system disorders Allergic reaction	11.1% 1/9 • Up to 8 months
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Up to 8 months
Musculoskeletal and connective tissue disorders Buttock Pain	11.1% 1/9 • Up to 8 months
Product Issues Delirium	11.1% 1/9 • Up to 8 months
Nervous system disorders Dizziness	11.1% 1/9 • Up to 8 months
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 3/9 • Up to 8 months
General disorders Edema limbs	11.1% 1/9 • Up to 8 months
General disorders Non-cardiac chest pain	11.1% 1/9 • Up to 8 months
Investigations Platelet count decreased	11.1% 1/9 • Up to 8 months
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Up to 8 months

Other adverse events

Measure	MLN0128 n=9 participants at risk Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone. MLN0128
Renal and urinary disorders Urinary frequency	88.9% 8/9 • Up to 8 months
General disorders Fatigue	100.0% 9/9 • Up to 8 months
Metabolism and nutrition disorders Anorexia	77.8% 7/9 • Up to 8 months
Gastrointestinal disorders Mucositis	77.8% 7/9 • Up to 8 months
Skin and subcutaneous tissue disorders Rash	100.0% 9/9 • Up to 8 months
Gastrointestinal disorders Constipation	55.6% 5/9 • Up to 8 months
Gastrointestinal disorders Nausea	44.4% 4/9 • Up to 8 months
Gastrointestinal disorders Diarrhea	77.8% 7/9 • Up to 8 months
General disorders Pain	100.0% 9/9 • Up to 8 months
Respiratory, thoracic and mediastinal disorders Dyspnea	88.9% 8/9 • Up to 8 months
General disorders Edema	44.4% 4/9 • Up to 8 months
Gastrointestinal disorders Vomiting	33.3% 3/9 • Up to 8 months
Nervous system disorders Dizziness	22.2% 2/9 • Up to 8 months
Psychiatric disorders Delirium	11.1% 1/9 • Up to 8 months

Additional Information

Dr. Dana Rathkopf, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4379

Email: rathkopd@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place