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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Rucaparib can help control endometrial cancer after previous treatments. Researchers aim to determine if Rucaparib can serve as an effective maintenance therapy for women with advanced or recurring endometrial cancer who have already tried one or two other treatments. Participants will receive either Rucaparib or a placebo (a pill with no active ingredients) to compare outcomes. Women who have completed prior cancer treatments and have advanced endometrial cancer might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rucaparib is generally well-tolerated by patients with endometrial cancer. In studies, patients have used rucaparib as a maintenance treatment. While rucaparib can cause side effects, many patients manage them well. Although specific details of these effects are not provided, the fact that rucaparib is in a Phase 2 study suggests confidence in its safety. If rucaparib were unsafe, it would not have progressed to this stage of research, indicating that the treatment has been previously tested for safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial cancer?

Rucaparib is unique because it offers a targeted approach for endometrial cancer by inhibiting the enzyme PARP (poly ADP-ribose polymerase). Most treatments for endometrial cancer involve surgery, radiation, or chemotherapy, which can affect both cancerous and healthy cells. Rucaparib, however, specifically targets cancer cells by exploiting their DNA repair weaknesses, potentially reducing side effects and improving outcomes. Researchers are excited about this treatment because it represents a more precise method of attacking cancer cells while sparing healthy ones, which could lead to better patient experiences and outcomes.

What evidence suggests that Rucaparib might be an effective treatment for endometrial cancer?

Research shows that Rucaparib, one of the treatments in this trial, can help people with advanced and returning endometrial cancer. Participants in this trial will be randomized to receive either Rucaparib or a placebo. One study found that patients taking Rucaparib experienced a longer time before their cancer worsened compared to those taking a placebo, which contains no active medicine. Another study showed that people on Rucaparib lived longer overall, but the exact average survival time remains unknown, while those on the placebo lived an average of 28.4 months. Rucaparib belongs to a group of drugs called PARP inhibitors, which have been helpful in treating cancers related to BRCA gene changes. These findings suggest Rucaparib could provide important benefits for managing this type of cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Bradley Corr, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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

Hemoglobin > or = 9.0 g/dL

Serum albumin > or = 2.5 g/dL

Exclusion Criteria

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

Participation in investigational clinical trial within last 30 days

I have significant liver disease or high liver enzyme levels.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40700852/

A phase II, randomized, double-blind study of the ... - PubMed Median overall survival was not reached in the rucaparib arm compared to 28.4 months in the placebo arm; hazard ratio 0.43 (95 % CI, 0.18-1.05).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825009187

A phase II, randomized, double-blind study of the use ... This trial evaluated the efficacy and safety of rucaparib maintenance therapy compared with placebo in patients with advanced or recurrent endometrial cancer.

3. onclive.com onclive.com/view/rucaparib-maintenance-therapy-displays-activity-in-pretreated-recurrent-metastatic-endometrial-cancer

Rucaparib Maintenance Therapy Displays Activity in ... Rucaparib maintenance therapy significantly improves progression-free survival in recurrent/metastatic endometrial cancer compared to placebo, with a median PFS ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03617679

Study Details | NCT03617679 | Rucaparib vs Placebo ... This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5626

A phase II, randomized, double-blind study of the use ... The PARP inhibitor drug class has demonstrated significant clinical benefit as a maintenance therapy for patients with germline/somatic BRCA ...

6. news.cuanschutz.edu news.cuanschutz.edu/cancer-center/rucaparib-extends-progression-free-survival-for-uterine-cancer

Clinical Trial Shows Rucaparib Extends Progression-Free ... Patients on placebo had a progression-free survival of nine months, whereas it was 28 months for those who had received rucaparib. This is very ...