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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.

Must not have

Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.

Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take pills by mouth or have stomach issues that affect medication absorption.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I am not currently using strong or moderate CYP3A inhibitors, or can stop them for 2 weeks before starting olaparib.

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I do not have active hepatitis B or C.

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I have never been treated with a PARP inhibitor like olaparib.

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I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

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I have not had major surgery in the last 2 weeks or have fully recovered from it.

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I have had a bone marrow or double cord blood transplant.

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I have lasting side effects from cancer treatment, but not hair loss.

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I am not currently using certain strong or moderate drugs that affect drug metabolism.

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I have a serious health condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response or Stable Disease to Olaparib Therapy at Six Months

Secondary study objectives

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 study objectives

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%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Thrombocytopenia

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2190

0 / 18Eligibility criteria met