Saruparib for Ovarian Cancer

Not currently recruiting at 12 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Corticosteroids, QT-prolonging drugs

Disqualifiers: Pancytopenia, Brain metastases, Immunodeficiency, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer treatment called saruparib for women with advanced or recurring ovarian cancer. Researchers aim to assess the safety and effectiveness of saruparib, both alone and in combination with other treatments. The trial seeks participants with a specific gene mutation (BRCA) and newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants using certain drugs that affect heart rhythm. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that saruparib is likely to be safe for humans?

Research shows that saruparib has been well tolerated by patients with advanced solid tumors. One study found that saruparib, which targets a protein called PARP1, produced promising results and was well tolerated at all doses. Another study showed that it blocked about 90% of PARP activity in tumor samples, indicating effective action against cancer cells with few safety concerns. This means the treatment achieved good results without causing many serious side effects. Overall, evidence suggests saruparib is safe for use in humans, based on these studies. ^{1 2 3 4 5}

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

Saruparib is unique because it offers a fresh approach to treating ovarian cancer by targeting specific enzymes involved in DNA repair. Unlike standard treatments such as chemotherapy and PARP inhibitors, Saruparib's mechanism of action is designed to more precisely home in on cancer cells with damaged DNA, potentially leading to fewer side effects. Researchers are excited about Saruparib because its targeted approach could improve outcomes for patients who don't respond well to existing therapies.

What evidence suggests that saruparib might be an effective treatment for ovarian cancer?

Research has shown that saruparib, the investigational treatment in this trial, offers promising results for patients with specific genetic changes in ovarian cancer. In previous studies, nearly half of the patients taking saruparib experienced tumor shrinkage. On average, the treatment prevented cancer progression for about 9 months. The drug targets certain genetic changes in cancer cells, making it a potential option for those with BRCA mutations in ovarian cancer. Early evidence suggests it could be both effective and safe for patients with these mutations. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or recurrent ovarian cancer. Specifically, Substudy 1 focuses on those with BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer. The eligibility criteria are not fully listed here.

Inclusion Criteria

I have not received any treatment for my condition.

Life expectancy at the time of screening ≥ 12 weeks

Measurable disease as per RECIST 1.1 criteria: at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter

Exclusion Criteria

My brain or spinal tumors are stable and not causing symptoms.

I have not had major surgery or significant injury recently.

I have had severe low blood cell counts for more than 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive saruparib monotherapy as neoadjuvant treatment

12 weeks

Visits on Day 1 of each 28-day cycle

Interval Debulking Surgery (IDS)

Participants undergo surgery to remove any remaining tumor

Within 6 weeks after treatment

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Saruparib

Trial Overview The study is examining the effects of saruparib either alone or in combination with other treatments on ovarian cancer patients. It aims to assess safety, tolerability, initial effectiveness, and how the body processes and responds to the drug.

How Is the Trial Designed?

Group I: Saruparib Experimental Treatment 1 Intervention

Participants will receive saruparib via oral administration.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. onclive.com onclive.com/view/first-in-class-parp1-selective-inhibitor-saruparib-shines-in-phase-1-trial-of-advanced-solid-tumors

First-in-Class PARP1 Selective Inhibitor Saruparib Shines ... Most importantly, at the recommended phase 2 dose of 60 mg once daily, we saw an ORR of 48.4% and a median PFS of 9.1 months. What are the next ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11348616/

The PARP1 selective inhibitor saruparib (AZD5305) elicits ... We demonstrate that AZD5305 elicits improved and sustained response in vivo in tumors with HRR mutations both alone or in combination with ...

3. esmoopen.com esmoopen.com/article/S2059-7029(24)01754-X/fulltext

Long-term outcomes of PARP inhibitors in ovarian cancer In the ITT population, OS favored the control arm with a median of 19.4 months in the rucaparib group versus 25.4 months in the chemotherapy ...

4. cancernetwork.com cancernetwork.com/view/saruparib-shows-favorable-activity-safety-in-mutant-advanced-solid-tumors

Saruparib Shows Favorable Activity, Safety in Mutant ... Saruparib at 20 mg once daily yielded a median best change in tumor size of –22.1% (range, –91.2% to 133.3%), an overall response rate (ORR) of ...

5. genomemedicine.biomedcentral.com genomemedicine.biomedcentral.com/articles/10.1186/s13073-024-01370-z

The PARP1 selective inhibitor saruparib (AZD5305) elicits ... We demonstrate that AZD5305 elicits improved and sustained response in vivo in tumors with HRR mutations both alone or in combination with ...

6. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/next-generation-parp-inhibitor-demonstrates-clinical-benefit-in-patients-with-homologous-recombination-repair-deficient-breast-cancer/

Next-generation PARP Inhibitor Demonstrates Clinical ... At the molecular level, saruparib inhibited around 90% of PARP activity in tumor tissue collected from biopsies. “The excellent safety and ...