145 Participants Needed

Olaparib for Advanced Cancer

Recruiting at 54 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in the body (metastatic) and that does not respond to treatment (refractory). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for specific drugs. If you are taking strong or moderate CYP3A inhibitors or inducers, you will need to stop them 2 to 5 weeks before starting the trial. It's important to discuss your current medications with the trial team to ensure they don't interact with the study drug.

Is Olaparib safe for humans?

Olaparib (Lynparza) has been studied for safety in various cancers, including breast and ovarian cancer. It generally has a manageable safety profile, meaning side effects are present but can be controlled. It has been tested in different populations, including Japanese patients with advanced solid tumors, showing it is generally safe for human use.12345

How is the drug Olaparib unique in treating advanced cancer?

Olaparib is unique because it is a PARP inhibitor (a type of drug that blocks an enzyme involved in repairing damaged DNA) and is used specifically for cancers with BRCA mutations, making it a personalized treatment option. It is taken orally, which can be more convenient compared to some other cancer treatments that require intravenous administration.14567

What data supports the effectiveness of the drug Olaparib (Lynparza) for advanced cancer?

Olaparib (Lynparza) has shown effectiveness in treating ovarian cancer, particularly in patients with BRCA mutations, by helping to shrink tumors and delay disease progression. It is also approved for use in high-risk early breast cancer with similar genetic mutations, indicating its potential effectiveness in other advanced cancers with these mutations.14678

Who Is on the Research Team?

Patricia LoRusso, DO < Yale School of ...

Patricia M Lorusso

Principal Investigator

Yale University Cancer Center LAO

Are You a Good Fit for This Trial?

Adults with advanced glioma, cholangiocarcinoma, or solid tumors that have IDH1/IDH2 mutations and are treatment-resistant can join. They must meet certain health criteria like blood cell counts, organ function tests, agree to use contraception if applicable, and be willing to undergo biopsies. Those with recent major surgery, uncontrolled medical issues, HIV/hepatitis or a history of other cancers may not qualify.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Leukocytes >= 3,000/mcL
Platelet count >= 100 x 10^9/L
See 23 more

Exclusion Criteria

I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
I do not have any serious, uncontrolled health issues or infections.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olaparib orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 1 year
Monthly visits for CT/MRI scans, tumor biopsy, and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Olaparib
Trial Overview The trial is testing Olaparib's effectiveness on patients whose cancer has spread and doesn't respond to standard treatments. It involves taking the drug orally and monitoring its impact through various assessments including biopsies and imaging techniques like CT scans and MRIs.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment5 Interventions
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Lynparza for:
  • Breast cancer
  • Ovarian cancer
  • Fallopian tube cancer
  • Peritoneal cancer
  • Pancreatic cancer
  • Prostate cancer
  • Endometrial cancer
🇺🇸
Approved in United States as Lynparza for:
  • Ovarian, fallopian tube, and primary peritoneal cancer
  • Breast cancer
  • Prostate cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Olaparib (Lynparza) is approved for treating adult patients with high-risk early breast cancer that has a germline BRCA mutation, following chemotherapy treatment.
This approval highlights Olaparib's role as an adjuvant therapy, which means it is used after initial treatments to help prevent cancer recurrence.
New Adjuvant Treatment for High-Risk Early Breast Cancer.Aschenbrenner, DS.[2022]
Olaparib, a PARP inhibitor, showed a 36% objective response rate in women with relapsed ovarian cancer and a germline BRCA1/2 mutation, even after they had undergone multiple lines of chemotherapy, indicating its efficacy in this challenging patient population.
The median duration of response to olaparib was 7.4 months, and the safety profile was consistent across patients who had received three or more lines of prior chemotherapy, with similar rates of serious adverse events.
Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety.Matulonis, UA., Penson, RT., Domchek, SM., et al.[2022]
Olaparib is an effective oral treatment for patients with BRCA mutation-positive ovarian cancer, approved for maintenance therapy after platinum-based chemotherapy, showing good tolerability with common side effects like nausea, fatigue, and anemia being mild to moderate.
Long-term monitoring is recommended due to a low risk of serious hematological complications, such as anemia and myelodysplastic syndrome, ensuring patient safety during treatment.
Safety evaluation of olaparib for treating ovarian cancer.Lheureux, S., Bowering, V., Karakasis, K., et al.[2015]

Citations

New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]
Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. [2022]
Safety evaluation of olaparib for treating ovarian cancer. [2015]
Olaparib: first global approval. [2020]
Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design. [2020]
Safety and tolerability of the olaparib tablet formulation in Japanese patients with advanced solid tumours. [2022]
Olaparib for the treatment of breast cancer. [2019]
Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes. [2020]
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