A Study Evaluating The Safety Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).

STATUS

Recruiting
participants needed

50
sponsor

Hoffmann-La Roche

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Updated on 19 February 2024

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cancer

metastasis

atezolizumab

bone lesions

docetaxel

adenocarcinoma

targeted therapy

luteinizing hormone

prostate adenocarcinoma

metastatic disease

gnrh

drug test

gonadotropin releasing hormone

testosterone

lymphadenopathy

neuropathy

bone scan

adenocarcinoma of prostate

medical castration

bone lesion

castration-resistant prostate cancer

adenopathy

progression of prostate cancer

hair thinning

prostate cancer

metastatic hormone refractory prostate cancer

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.

Details

Condition	Malignant neoplasm of prostate
Age	18-100 years
Treatment	Atezolizumab, Docetaxel, Ipatasertib
Clinical Study Identifier	NCT04404140
Sponsor	Hoffmann-La Roche
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 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 Exclusion Criteria
	Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
	History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
	Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
	Treatment with strong CYP3A inhibitor or strong CYP3A inducer within 2 weeks or 5 drug-elimination half-lives of this treatment (whichever is longer) prior to initiation of study drug
	Atezolizumab-Specific Exclusion Criteria
	Active or history of autoimmune disease or immune deficiency
	History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
	Prior allogeneic stem cell or solid organ transplantation
	Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the last dose of atezolizumab
	History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
	Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies
	Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug (whichever is longer) prior to initiation of study treatment
	Need for chronic corticosteroid therapy of >10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
	Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
	Docetaxel-Specific Exclusion Criteria
	Known hypersensitivity or contraindication to any component of docetaxel, including its excipient polysorbate 80
	Grade >= 2 peripheral neuropathy

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bone lesion

castration-resistant prostate cancer

adenopathy

progression of prostate cancer

hair thinning

prostate cancer

metastatic hormone refractory prostate cancer

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Study Definition

Wikipedia

A Study Evaluating The Safety Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).