150 Participants Needed

Olaparib for Bladder Cancer

Recruiting at 17 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

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires a washout period (time without taking certain medications) of 2 weeks for chemotherapy and 4 weeks for monoclonal antibodies before starting the study. Additionally, if you are taking strong or moderate CYP3A inhibitors or inducers, you will need a washout period of 5 half-lives or 3 weeks, whichever is shorter. Please consult with your doctor about your specific medications.

What data supports the effectiveness of the drug Olaparib for bladder cancer?

Olaparib, a drug originally used for ovarian cancer, has shown promise in treating tumors with specific genetic mutations (BRCA1/BRCA2). While direct evidence for bladder cancer is limited, a study suggests that Olaparib may work well in bladder cancer cells, especially when combined with another drug called Metformin.12345

Is Olaparib generally safe for humans?

Olaparib, also known as Lynparza, has been used in various cancer treatments and is generally considered to have a manageable safety profile. Common side effects include nausea, fatigue, and anemia, while more serious effects like myelodysplastic syndrome (a blood disorder) and acute myeloid leukemia (a type of blood cancer) are rare.12678

How is the drug Olaparib unique in treating bladder cancer?

Olaparib is unique because it is a poly (ADP-ribose) polymerase (PARP) inhibitor, which works by targeting cancer cells with BRCA mutations, a mechanism not commonly used in bladder cancer treatments. It is an oral medication, which can be more convenient compared to traditional intravenous chemotherapy.124910

What is the purpose of this trial?

This trial studies how well olaparib works in patients with advanced bladder and other genitourinary cancers that have DNA-repair defects. Olaparib is a drug that stops cancer cells from fixing their damaged DNA, which can help to stop the cancer from growing. The trial targets patients whose cancers have spread and are not responsive to standard treatments.

Research Team

AB

Andrea B Apolo

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

Adults with advanced bladder cancer or genitourinary tumors that have DNA-repair defects and can't be cured by standard treatments. Participants must have specific genetic changes, provide a tumor sample, not be pregnant or fathering children, and meet certain health criteria like good organ function and blood counts.

Inclusion Criteria

I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.
My genetic test shows benign or uncertain results.
Women of child-bearing potential and their partners should agree to use two (2) highly effective forms of contraception throughout study participation and for at least one (1) month after the last dose of olaparib. Male study participants should avoid fathering a child or donating sperm during the study and for three (3) months after the last dose of olaparib
See 16 more

Exclusion Criteria

You have had allergic reactions to drugs similar to olaparib.
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
I have lasting side effects from cancer treatment, except for hair loss.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive olaparib orally twice daily on days 1-28 of each cycle, with cycles repeating every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle, ongoing
Regular visits for blood sample collection, imaging, and optional biopsies

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 4 weeks, every 2 months for 1 year, then every 3 months thereafter.

Up to 5 years
Follow-up visits every 2 months for 1 year, then every 3 months

Treatment Details

Interventions

  • Olaparib
Trial Overview The trial is testing Olaparib, a PARP inhibitor designed to prevent cancer cells from repairing their DNA, potentially stopping their growth. It's for patients whose cancer has spread and involves collecting biospecimens to study the treatment's effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort II (biospecimen collection)Experimental Treatment7 Interventions
Patients that do not have cancer-associated DNA-repair gene mutations undergo blood sample collection at baseline. Additionally, patients undergo CT, MRI, PET/CT, or bone scan and optional tumor biopsy and bone marrow biopsy on study.
Group II: Cohort I (olaparib)Experimental Treatment8 Interventions
Patients that have cancer-associated DNA-repair gene mutations receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, MRI, PET/CT, or bone scan and optional tumor biopsy and bone marrow biopsy 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+

Findings from Research

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 first-line maintenance treatment for adults with advanced ovarian cancer who have responded to platinum-based chemotherapy, significantly improving progression-free survival compared to placebo in phase III trials.
When combined with bevacizumab, olaparib further enhances treatment efficacy in patients with homologous recombination deficiency (HRD), but does not show benefits in HRD-negative tumors, indicating its targeted effectiveness.
Olaparib: A Review as First-Line Maintenance Therapy in Advanced Ovarian Cancer.Paik, J.[2022]
Olaparib is a powerful inhibitor of PARP-1 and PARP-2, showing effectiveness in treating ovarian cancer, particularly in patients with germline BRCA mutations.
Phase III trials are currently evaluating olaparib's efficacy as a maintenance therapy after initial treatment in patients with BRCA mutations, highlighting its potential role in long-term cancer management.
Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer.Gunderson, CC., Moore, KN.[2016]

References

Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. [2022]
Olaparib: A Review as First-Line Maintenance Therapy in Advanced Ovarian Cancer. [2022]
Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. [2016]
Olaparib: a review of its use as maintenance therapy in patients with ovarian cancer. [2016]
Metformin Can Enhance the Inhibitory Effect of Olaparib in Bladder Cancer Cells. [2022]
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. [2022]
Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer. [2022]
New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]
Olaparib: first global approval. [2020]
Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design. [2020]
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