Status:
TERMINATED
A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Castration-Resistant Prostatic Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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-generat...
Eligibility Criteria
Inclusion
- 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
- Prior treatment with an AKT, PI3K, or mTOR inhibitor.
- Prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- Prior treatment with docetaxel or another chemotherapy agent for mCRPC.
- Treatment with investigational therapy within 14 days prior to initiation of study drug.
- History or known presence of central nervous system metastases including leptomeningeal carcinomatosis.
- Uncontrolled tumor-related pain.
- Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment.
- Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco- regional therapy if appropriate prior to enrollment.
- Non-study-related minor surgical procedures =\< 5 days or major (invasive) surgical procedure =\< 28 days prior to the first dose of study treatment.
- Active Hepatitis B and C infection (HBV/HCV).
- Known HIV infection.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment.
- Malabsorption syndrome or other condition that would interfere with enteral absorption.
- Serious infection requiring antibiotics within 14 days prior to the first dose of study treatment.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
- History of another malignancy within 5 years prior to enrollment.
- History of clinically significant cardiovascular dysfunction.
- Presence of any other condition, metabolic dysfunction, physical examination finding, or laboratory finding that may increase the risk associated with study participation or may interfere with the interpretation of study results and in the opinion of the investigator, would make the participant inappropriate for study entry.
- Ipatasertib-Specific
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04404140
Start Date
July 9 2020
End Date
October 14 2022
Last Update
October 17 2023
Active Locations (9)
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1
HOPITAL JEAN MINJOZ; Oncologie
Besançon, France, 25030
2
Centre Val Aurelle Paul Lamarque; Radiotherapie
Montpellier, France, 34928
3
Hopital d'Instruction des Armees de Begin
Saint-Mandé, France, 94160
4
Gustave Roussy
Villejuif, France, 94805