Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID)
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|ClinicalTrials.gov Identifier: NCT03786796|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Kidney Cancer Renal Carcinoma Kidney Cancer Metastatic||Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)|
|Actual Study Start Date :||June 3, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
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 that have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy with measureable disease on CT imaging according to RECIST 1.1 criteria. Participants will be initially treated with olaparib 150mg by mouth twice daily for one month. After one month of therapy, the dose will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater adverse events experienced. Reassessment will occur at least monthly for toxicity. Radiological scans will be performed every 3 months to assess disease response. Treatment will be continued until clinical and/or radiographic progression according to RECIST 1.1 criteria or unmanageable toxicity requiring cessation.
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.
- Objective Response or Stable Disease to Olaparib Therapy at Six Months [ Time Frame: 6 months post-intervention ]Complete response (CR) or partial response (PR) at any time on study or stable disease (SD) after 6 months of Olaparib treatment, based on RECIST 1.1 criteria.
- Safety of Olaparib Therapy As Determined by the Number of Adverse Events [ Time Frame: 2 years ]Number of Adverse Events, Grade 3 or higher as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Median Progression-Free Survival to Olaparib Therapy [ Time Frame: 2 years ]Number of months from the time of initiation on Olaparib therapy until radiographic progression or death, whichever comes first while enrolled on the study, based on RECIST 1.1 criteria.
- Rate of Objective Response to Olaparib Therapy [ Time Frame: 2 years ]Number of participants with best overall response (complete response (CR) or partial response (PR)) at anytime on study.
- Reversion Mutations in Circulating Tumor DNA (ctDNA) at Clinical Progression [ Time Frame: 2 years ]Number of incidences of reversion mutations in circulating tumor DNA (ctDNA) at time of clinical progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786796
|Contact: Irina Rifkind, RN, MSNfirstname.lastname@example.org|
|Contact: Rana Sullivan, RN, BSNemail@example.com|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21228|
|Contact: Irina Rifkind, RN/MSN 410-502-2043 firstname.lastname@example.org|
|Principal Investigator: Mark Markowski, MD/PhD|
|Principal Investigator:||Mark C Markowski, MD, Ph.D||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|