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RecruitingPhase 2NCT03786796

Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations

Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

20 participants

Start Date

Jun 3, 2019

Study Type

INTERVENTIONAL

Conditions

Metastatic Renal Cell CarcinomaRenal Cell CarcinomaKidney CancerRenal CarcinomaKidney Cancer Metastatic

Summary

Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether olaparib — a targeted drug originally used for ovarian and breast cancer with DNA repair gene mutations — can also work for patients with metastatic kidney cancer (cancer that has spread beyond the kidney) who have mutations in similar DNA repair genes. **You may be eligible if...** - You are 18 or older and have provided written consent - You have metastatic kidney cancer confirmed by biopsy (any cell type is allowed) - Your cancer has a genetic mutation in one of these DNA repair genes: BAP-1, ATM, BRCA1, BRCA2, PALB2, or similar genes **You may NOT be eligible if...** - Your cancer does not have a qualifying DNA repair gene mutation - You have not yet had your tumor tested for these mutations - You have conditions that prevent safe use of olaparib (such as severe bone marrow problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib

Olaparib is a crystalline solid, is non-chiral and shows pH-independent solubility of approximately 0.1 mg/mL across the physiological range. Olaparib is presented for oral administration as a green, film-coated tablet containing 25 mg, 100 mg or 150 mg of drug substance. The 100 mg strength is also available as a yellow, film-coated tablet. The 25 mg, 100 mg and 150 mg strengths of olaparib tablets are composed of the same constituents. The tablet cores comprise: olaparib, copovidone, colloidal silicon dioxide, mannitol and sodium stearyl fumarate. The composition of the green tablet film coating is: hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. The yellow tablet film coating only differs from the green film coating with the omission of iron oxide black.

Locations(1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

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NCT03786796

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