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PARP Inhibitor

Olaparib for Kidney Cancer (ORCHID Trial)

Phase 2
Recruiting
Led By Mark C Markowski, MD, Ph.D
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one prior treatment with an anti-angiogenic agent or immune checkpoint inhibitor.
Somatic or germline mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L as documented by a clinical CLIA-grade, tissue, saliva or blood-based genetic test.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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

Who is the study for?
Adults with metastatic renal cell carcinoma and specific gene mutations who've had prior anti-cancer treatments can join. They must have a certain level of blood counts, organ function, and life expectancy. Women should not be pregnant or breastfeeding, and men must use contraception.Check my eligibility
What is being tested?
The trial is testing the oral drug Olaparib in patients with kidney cancer that has spread and contains certain DNA repair gene mutations. It's an open-label Phase II study where all participants receive the medication to see how it affects their cancer.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, shortness of breath, headache, loss of appetite and taste changes.

ORCHID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with medication that stops tumors from making new blood vessels or boosts my immune system.
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I have a mutation in one of the specified genes.
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My organ and bone marrow functions are normal as tested within the last 28 days.
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I have had previous treatments for my condition, including immunotherapy or clinical trials.
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I am 18 years old or older.
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I am postmenopausal or not pregnant, confirmed by a recent test.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I will use a condom during and for 3 months after treatment if my partner is pregnant or can become pregnant.
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My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.
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I have been diagnosed with renal cell carcinoma.
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My kidney cancer has spread to other parts of my body.
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My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.

ORCHID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response or Stable Disease to Olaparib Therapy at Six Months
Secondary outcome measures
Median Progression-Free Survival to Olaparib Therapy
Rate of Objective Response to Olaparib Therapy
Safety of Olaparib Therapy As Determined by the Number of Adverse Events
Other outcome measures
Reversion Mutations in Circulating Tumor DNA (ctDNA) at Clinical Progression

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

ORCHID Trial Design

1Treatment groups
Experimental Treatment
Group I: OlaparibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,860 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,245 Previous Clinical Trials
288,529,228 Total Patients Enrolled
Mark C Markowski, MD, Ph.DPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03786796 — Phase 2
Kidney Cancer Research Study Groups: Olaparib
Kidney Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03786796 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03786796 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Does this research include elderly participants?

"This medical trial is enrolling individuals over the age of 18 and below 120 years old."

Answered by AI
~3 spots leftby Mar 2025