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

Study acronym: ORCHID
StatusRecruiting
PhasePhase 2
Started2019-06-03
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status v12
Re-verified, no change to tracked fields
2025-03-10
Study Status v11
Primary completion date2025-03→2027-03
Completion date2026-03→2028-03
2024-03-04
Study Status v10
Primary completion date2024-03→2025-03
Completion date2025-03→2026-03
2023-04-18
Study Status, Eligibility v9
Eligibility criteriarevised
[...] ld be excluded. Patients must have a creatinine clearance ≥ 5140 mL/min calculated by Cockroft-Gault formula or 24 hour urin [...]
2023-03-01
Study Status v8
Primary completion date2023-03→2024-03
Completion date2024-03→2025-03
Show 7 earlier versions
2022-03-14
Study Status v7
Primary completion date2022-03→2023-03
Completion date2023-03→2024-03
2021-03-10
Study Status v6
Primary completion date2021-03→2022-03
Completion date2022-03→2023-03
2020-06-04
Study Status v5
Re-verified, no change to tracked fields
2019-06-03
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-05→confirmed 2019-06-03
Eligibility criteriarevised
[...] itting the infection through blood or other body fluids. No Packedpacked red blood cells and/or platelet transfusions within the last 28 days prior to study entry.
Study sitesdetails revised at 1 of 1 site
2019-05-10
Study Status, Eligibility, Contacts/Locations v3
Study sites0→1
Eligibility criteria+3 characters
[...] nsmitting the infection through blood or other body fluids. No Packed red blood cells and/or platelet transfusions within the last 28 days prior to study entry.
2019-04-30
Study Status v2
Start date2019-03→2019-05
2019-01-07
Study Status, Eligibility v1
Eligibility criteria+85 characters
[...] sferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) <≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be <≤ 5x5 x ULN. Note: Patients with elevations in bilirubin, AST, or A [...] tients with evidence of viral infection should be excluded. Serum Creatinine: Patients must have a creatinine clearance >≥ 51 mL/min calculated by Cockroft-Gault formula or 24 hour urine test. ECOG PS ≤ 1. Participants must have a life expectancy ≥ 16 [...] or more following cessation of exogenous hormonal treatments. Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) leve [...] [...]
2018-12-21
Original filing
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.
Trial Details
NCT Number NCT03786796
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: AstraZeneca
Conditions Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Renal Carcinoma, Kidney Cancer Metastatic
Enrollment 20 participants
Start Date 2019-06-03
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-30