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Olaparib for Kidney Cancer (ORCHID Trial)
ORCHID Trial Summary
This trial is testing the effects of olaparib on metastatic renal cell carcinoma that has a mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L. The trial is open-label, meaning that both the doctors and participants know what treatment is being given. This trial is for people who have had prior treatment with at least one immune checkpoint
ORCHID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowORCHID Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT02184195ORCHID Trial Design
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- I cannot take pills by mouth or have stomach issues that affect medication absorption.I haven't had any blood or platelet transfusions in the last 28 days.Your platelet count is at least 100 billion per liter.Your white blood cell count is at least 1.5 times 10 raised to the power of 9 per liter.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.Your liver enzymes (AST/SGOT and ALT/SGPT) should not be too high, unless you have cancer in your liver, in which case they can be a little higher.I have been treated with medication that stops tumors from making new blood vessels or boosts my immune system.I have a mutation in one of the specified genes.I am not currently using strong or moderate CYP3A inhibitors, or can stop them for 2 weeks before starting olaparib.You have a weakened immune system, such as being HIV positive.My organ and bone marrow functions are normal as tested within the last 28 days.I have had previous treatments for my condition, including immunotherapy or clinical trials.I do not have active hepatitis B or C.I am 18 years old or older.I have never been treated with a PARP inhibitor like olaparib.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I am postmenopausal or not pregnant, confirmed by a recent test.I have not had major surgery in the last 2 weeks or have fully recovered from it.I've been cancer-free for 5+ years, except for certain skin, cervical, breast, or endometrial cancers.I have had a bone marrow or double cord blood transplant.Your bilirubin levels are not too high.I am fully active and can carry on all my pre-disease activities without restriction.I have lasting side effects from cancer treatment, but not hair loss.I will use a condom during and for 3 months after treatment if my partner is pregnant or can become pregnant.You are allergic to olaparib or any of the ingredients in the medication.You must have a detectable disease that can be measured using specific criteria called RECIST 1.1.My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.I have been diagnosed with renal cell carcinoma.I don't have uncontrolled brain metastases or untreated spinal cord compression.I do not have serious heart issues or a family history of long QT syndrome.I am not currently using certain strong or moderate drugs that affect drug metabolism.My kidney cancer has spread to other parts of my body.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.I have a serious health condition that is not under control.
- Group 1: Olaparib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment currently open for this trial?
"As indicated by clinicaltrials.gov, this investigation remains open for participant enrollment. The trial was initially posted on June 3rd 2019 and underwent its most recent update on March 14th 2022."
How many participants have been enlisted in this trial thus far?
"Affirmative. Clinicaltrials.gov's data suggests that a recruitment drive for this research project commenced on June 3rd 2019 and has most recently been updated on March 14th 2022. The plan is to enrol 20 individuals from one medical centre."
What conditions does Olaparib ordinarily address?
"Olaparib is traditionally prescribed to manage advanced cases, but can also be used in the treatment of malignant neoplasm of ovary, primary peritoneal cancer and other somatic delusions."
What criteria must participants fulfill to be accepted in this research trial?
"This clinical trial is looking for 20 individuals aged 18 to 120 with renal cell carcinoma. To be eligible, applicants must meet the following qualifications: evidence of measurable disease according to RECIST 1.1 criteria; hemoglobin levels above 10 g/dL without blood transfusion in the past month; valid informed consent; histological proof of RCC (clear or non-clear); AJCC Stage IV metastatic cancer; mutation in BAP-1, ATM, etc.; prior experience with anti-angiogenic agents and immune checkpoint inhibitors allowed but not required; ANC ≥ 1.5 x 10^9/L."
Has Olaparib received regulatory validation from the FDA?
"Olaparib's safety is rated at 2 on our scale, as the clinical trial in question is a Phase 2 trial which indicates that there has been some proof of security but no data demonstrating efficacy."
Is this a pioneering trial for its type?
"At present, 188 trials of Olaparib are being conducted in 59 countries, covering 1468 cities. In 2005, AstraZeneca launched a Phase 1 trial for this drug with 98 participants and since then 63 studies have been completed successfully."
What other investigations have utilized Olaparib to discern data?
"Currently, Olaparib is being evaluated in 188 different clinical trials, 27 of which are Phase 3. This research has spread far and wide with Houston hosting some of the studies but more than 9250 sites around the world participating as well."
Does this research include elderly participants?
"This medical trial is enrolling individuals over the age of 18 and below 120 years old."
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