Saruparib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests saruparib, a new drug type known as a PARP inhibitor, to evaluate its effectiveness on certain cancer tumors. Specifically, it targets tumors with a special marker called HRDsig, indicating a potential better response to this treatment. Individuals with advanced or metastatic solid tumor cancer, who have not shown resistance to platinum-based chemotherapy, might be suitable candidates. The trial aims to determine if saruparib can effectively target and shrink these tumors. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that saruparib is likely to be safe for humans?
Research has shown that saruparib, a PARP inhibitor, has been tested in various cancers, including breast and prostate cancer. One study on breast cancer patients with specific DNA issues found saruparib to be generally safe, with most patients tolerating the treatment well.
In another study involving 141 patients taking a 60 mg dose, some experienced side effects. Specifically, 92.2% of these patients reported side effects, but only 12.1% were severe. This indicates that while side effects are common, most are not serious.
Independent experts have reviewed saruparib's safety in other studies, which adds confidence in its safety profile. Overall, saruparib is generally well-tolerated, though it can cause side effects like many treatments.12345Why do researchers think this study treatment might be promising?
Saruparib is unique because it works by inhibiting a protein called PARP, which plays a role in repairing damaged DNA in cancer cells. This mechanism makes it different from traditional chemotherapy, which attacks rapidly dividing cells indiscriminately. Researchers are excited about Saruparib because it targets cancer cells more precisely, potentially leading to fewer side effects and better effectiveness against certain types of cancer. Unlike some existing treatments, Saruparib could offer a more tailored approach, reducing harm to healthy cells and improving patient outcomes.
What evidence suggests that saruparib might be an effective treatment for cancer?
Studies have shown that saruparib, the investigational treatment tested in this trial, shows promise in treating cancer. Specifically, in breast cancer patients with certain DNA repair issues, about 48.4% experienced tumor shrinkage, meaning nearly half saw their tumors get smaller. Prostate cancer patients responded even better, with 88.5% seeing positive results. The drug also extended the period patients lived without their cancer worsening to about 9.1 months. These findings suggest that saruparib could effectively treat cancers with specific genetic traits.56789
Who Is on the Research Team?
Kim Reiss Binder, MD
Principal Investigator
Abramson Cancer Center at Penn Medicine
Are You a Good Fit for This Trial?
This trial is for people with solid tumors that test positive for a specific genetic signature called HRDsig, as determined by the FoundationOne®CDx test. Participants must have cancer and meet other medical requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive saruparib, an experimental PARP inhibitor, for the treatment of HRDsig+ solid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Saruparib
Trial Overview
The study is testing saruparib, an experimental drug known as a PARP inhibitor, in patients whose tumors are HRDsig-positive. The FoundationOne®CDx test is used to identify eligible participants.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Saruparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn Medicine
Lead Sponsor
AstraZeneca
Industry Sponsor
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
Basser Center for BRCA
Collaborator
Citations
Next-generation PARP Inhibitor Demonstrates Clinical ...
Among the 31 breast cancer patients treated with 60 mg saruparib, the objective response rate was 48.4%, the median duration of response was 7. ...
Saruparib Appears Safe, Active in Advanced Breast Cancer
The median progression-free survival (PFS) was 4.6 months with the 20 mg dose and 9.1 months with the 60 mg dose. PFS data were not available ...
3.
oncologynewscentral.com
oncologynewscentral.com/article/selective-parp1-inhibitor-shows-early-efficacy-in-hrr-mutant-advanced-breast-cancerSelective PARP1 Inhibitor Shows Early Efficacy in HRR- ...
Saruparib at 60 mg demonstrated deep and durable responses. ORR was 48.4%, and median PFS was 9.1 months, which was favorable compared with the ...
The PARP1 selective inhibitor saruparib (AZD5305 ... - PMC
AZD5305 showed superior antitumor activity than the first-generation PARPi in terms of preclinical complete response rate (75% vs. 37%).
5.
mdanderson.org
mdanderson.org/newsroom/aacr--parp1-selective-inhibitor-demonstrates-early-efficacy-breast-cancers-DNA-repair-defects.h00-159696756.htmlPARP1-selective inhibitor demonstrates early efficacy in ...
The objective response rate was 48.8% with a median progression-free survival of 9.1 months. The drug had favorable tolerability as well as ...
Phase III, randomized, double-blind, placebo-controlled ...
The Phase III EvoPAR-Prostate02 study (NCT06952803) is evaluating the efficacy and safety of adjuvant saruparib versus placebo in patients with ...
Saruparib for Prostate Cancer (EvoPAR-PR02 Trial)
Research shows that Saruparib has been tested for its effects and safety in people with advanced prostate cancer. In earlier studies, Saruparib showed promising ...
NCT06120491 | Saruparib (AZD5305) vs Placebo in Men ...
Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + ...
AZD5305 (Saruparib) Clinical Trials
Multiple clinical trials evaluate the therapeutic profile of saruparib (AZD5305) across various oncology indications, including advanced breast cancer, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.