A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With A… (NCT04404140) | Clinical Trial Compass
TerminatedPhase 1
A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Stopped: Despite many risk-minimization strategies, the combination of ipatasertib, atezolizumab and docetaxel was challenging due to multiple study treatment modifications required to manage toxicity, making further enrollment inappropriate.
France, Italy, Spain6 participantsStarted 2020-07-09
Plain-language summary
A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: \[1\] Part A: Safety run-in cohort of approximately 12 participants; \[2\] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to comply with the study protocol.
* Adenocarcinoma of the prostate without small-cell or neuroendocrine features.
* Metastatic disease that cannot be treated with curative intent.
* Surgical or medical castration with testosterone serum level \< 50 ng/dL (1.7 nM).
* For participants treated with luteinizing hormone-releasing hormone analogs, initiation therapy \>= 4 weeks prior to the first dose of study treatment and continued therapy throughout study treatment.
* Progression of Prostate Cancer.
* Receipt of at least one prior line of second generation AR-targeted therapy.
* For participants in Part A of study: measurable visceral disease or measurable extrapelvic adenopathy per RECIST v1.1.
* For participants in Part B of study: either measurable visceral disease or measurable extrapelvic adenopathy by RECIST v1.1 or bone lesions by bone scan, or both.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Life expectancy of \>= 3 months.
* Ability to swallow oral study drug.
* Adequate organ and bone marrow function.
* Resolved or stabilized toxicities resulting from previous therapy to Grade 1 (except for alopecia and neuropathy).
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
Exclusion Criteria:
* Prior treatment with an AKT, PI3K, or mTOR inhibitor.
* Prior treatment with radium or other therapeutic radiopha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants with Adverse Events (AEs)
Timeframe: Up to 35 months
2
Confirmed Prostate Specific Antigen (PSA) Response
Timeframe: Up to 35 months
3
Overall Response Rate (ORR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)