Rucaparib Maintenance Therapy for Endometrial Cancer

Overseen By Samantha Hopp

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Cardiovascular disease, Liver disease, CNS malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression

79 Participants Needed

Trial Summary

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Rucaparib for endometrial cancer?

Rucaparib has shown potential as a maintenance therapy in ovarian cancer, which suggests it might also be effective for endometrial cancer. Additionally, a study examined the combination of rucaparib with another drug in recurrent endometrial cancer, indicating ongoing research into its effectiveness for this condition. ^{1 2 3 4 5}

Is Rucaparib safe for humans?

Rucaparib has been studied for safety in patients with ovarian cancer, showing common side effects like tiredness, changes in taste, and stomach issues. Serious side effects occurred in some patients, leading to treatment discontinuation in about 16.2% of cases, so close monitoring is recommended. ^{1 2 3 4 6}

How does the drug rucaparib differ from other treatments for endometrial cancer?

Rucaparib is unique because it is a poly(ADP-ribose) polymerase (PARP) inhibitor, which means it works by blocking an enzyme that helps repair DNA damage in cancer cells, potentially making it effective as a maintenance therapy. While it is primarily used for ovarian cancer, its use in endometrial cancer is novel, as there are no standard PARP inhibitors approved for this condition. ^{1 2 4 7 8}

What is the purpose of this trial?

This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.

Research Team

Bradley Corr, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for women aged 18-89 with Stage III/IV or recurrent endometrial cancer who've had 1-2 prior chemo treatments. They must have completed their last chemo cycle at least 4 weeks ago, be in fairly good health (ECOG status of 0, 1, or 2), and have adequate blood counts and liver function. Women must not be pregnant and agree to use contraception.

Inclusion Criteria

Platelet count > 100,000 microliters

I am a woman aged between 18 and 89.

Hemoglobin > or = 9.0 g/dL

Exclusion Criteria

I do not have serious heart conditions like recent heart attacks or unstable heart disease.

I have significant liver disease or high liver enzyme levels.

Participation in investigational clinical trial within last 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rucaparib or placebo as maintenance therapy until disease progression

Until progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 48 months

Treatment Details

Interventions

• Placebo
• Rucaparib

Trial Overview The study tests Rucaparib as a maintenance therapy against a placebo in women with metastatic or recurrent endometrial cancer after they've received one to two lines of chemotherapy. The goal is to see if Rucaparib can help keep the cancer from growing back.

Participant Groups

Group I: Active Ingredient Active Control 1 Intervention

1:1 Randomization. Participants in this arm receive the active ingredient medication.

Group II: Placebo Placebo Group 1 Intervention

1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Clovis Oncology, Inc.

Industry Sponsor

Trials

65

Recruited

11,100+

Patrick J. Mahaffy

Clovis Oncology, Inc.

Chief Executive Officer since 2009

BA from Haverford College, MBA from Columbia University

Lindsey Rolfe

Clovis Oncology, Inc.

Chief Medical Officer since 2015

Specialist accreditation in pharmaceutical medicine

Findings from Research

Rucaparib, a poly(ADP-ribose) polymerase inhibitor, is effective as a treatment for relapsed ovarian cancer, but 61.8% of patients experience serious adverse events (AEs), highlighting the need for careful monitoring.

Common AEs include gastrointestinal issues, fatigue, and anemia, with 16.2% of patients discontinuing treatment due to these side effects; therefore, managing these AEs is essential for maintaining treatment adherence and improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Adverse Events During Rucaparib Treatment for Relapsed Ovarian Cancer: A Review of Published Studies and Practical Guidance. Lorusso, D., García-Donas, J., Sehouli, J., et al.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

Rucabarib: A new lease of life for ovarian cancer patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Population exposure-efficacy and exposure-safety analyses for rucaparib in patients with recurrent ovarian carcinoma from Study 10 and ARIEL2. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A phase II trial of bevacizumab and rucaparib in recurrent carcinoma of the cervix or endometrium. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Rucaparib: A Poly(ADP-Ribose) Polymerase Inhibitor for BRCA-Mutated Relapsed Ovarian Cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Genetic and molecular subtype heterogeneity in newly diagnosed early- and advanced-stage endometrial cancer. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Management of Adverse Events During Rucaparib Treatment for Relapsed Ovarian Cancer: A Review of Published Studies and Practical Guidance. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of absorption, distribution, metabolism, and excretion of [14C]-rucaparib, a poly(ADP-ribose) polymerase inhibitor, in patients with advanced solid tumors. [2021]

8. France pubmed.ncbi.nlm.nih.gov

Rucaparib: A Review in Ovarian Cancer. [2021]