At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically confirmed renal cell carcinoma (clear cell or non-clear cell)
- ✓Metastatic (AJCC Stage IV) disease
- ✓Somatic or germline mutation in BAP1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L
- ✕Other malignancy within 5 years (with specific exceptions)
- ✕Symptomatic uncontrolled brain metastases
- ✕Spinal cord compression without definitive treatment and clinical stability for 28 days
- ✕Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)
In Brief
A Phase 2 clinical trial evaluating Olaparib for Renal Cell Carcinoma and 4 related conditions. Currently recruiting, targeting 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.