TerminatedPhase 1/2

Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

Stopped: Sponsor-PI decision. An analysis of the primary endpoint concluded that the addition of ribociclib to standard of care enzalutamide did not demonstrate benefit, an all active subjects were removed from the study.

United States52 participantsStarted 2015-12-01

Plain-language summary

This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enzalutamide with ribociclib may be safe, tolerable and/or effective in treating metastatic, castrate-resistant, chemotherapy naive prostate cancer that retains retinoblastoma expression.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening procedures * Histological or cytological proof of prostate cancer * Documented progressive metastatic (m)CRPC based on at least one of the following criteria: * PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL * Soft-tissue progression defined as an increase \>= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions * Progression of bone disease (evaluable disease) or (new bone lesion\[s\]) by bone scan * Have testosterone \< 50 ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients on long term (\> 6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (w…

What they're measuring

Number of Dose Limiting Toxicity of Ribociclib (Phase IB)

Timeframe: 28 days

Number of Patients With a >= 50% Reduction in Prostate Specific Antigen (PSA) (Phase II)

Timeframe: 12 weeks

Trial details

NCT IDNCT02555189

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-07

Results submitted2025-09-25