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Protein Kinase Inhibitor
RP-3500 + PARP Inhibitors for Advanced Cancer (ATTACC Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Repare Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Ability to swallow and retain oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while on study therapy, every 6 weeks for first 5 months and then every 9 weeks thereafter
Awards & highlights
ATTACC Trial Summary
This trial is testing the safety and effectiveness of two drugs, Niraparib or Olaparib, when used with RP-3500 to treat advanced solid tumors. The goal is to find the maximum tolerated dose of RP-3500 and to see if the combination has any anti-tumor activity.
Who is the study for?
Adults over 18 with advanced solid tumors that no longer respond to standard treatments can join. They must have certain tumor biomarkers, be able to take oral meds, and not be pregnant. People who've had recent cancer treatments or surgery, other active cancers, brain metastases, high blood pressure, or a history of specific blood disorders cannot participate.Check my eligibility
What is being tested?
The trial is testing the combination of RP-3500 (camonsertib) with either niraparib or olaparib in patients with advanced solid tumors. It aims to find the safest dose level and see how well it works against these tumors while also studying how the body processes these drugs.See study design
What are the potential side effects?
Possible side effects include issues related to organ function such as blood cell counts and digestive health; however, specific side effects will depend on individual patient reactions and which drug combination they receive.
ATTACC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
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I can swallow and keep down pills.
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My advanced cancer has not responded to standard treatments.
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My tumor has specific markers identified by a certified lab test.
ATTACC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ while on study therapy, every 6 weeks for first 5 months and then every 9 weeks thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on study therapy, every 6 weeks for first 5 months and then every 9 weeks thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase Ib - Safety and Tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib) by assessing the grade and frequency of adverse events and serious adverse events.
Primary Phase 1b - Define Maximum Tolerated Dose of RP-3500-03 (camonsertib) in combination with niraparib or olaparib and Recommended Phase 2 Dose and preferred schedule by assessing frequency of Dose Limiting Toxicities observed at each dose level
Primary Phase 2 - Assess preliminary anti-tumor activity of RP-3500 (camonsertib) with niraparib or olaparib in patients with eligible advanced solid tumors
Secondary outcome measures
To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib - AUC
To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib -Cmax
To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib -Tmax
ATTACC Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase Ib Dose EscalationExperimental Treatment1 Intervention
Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with niraparib and/or Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with olaparib
Group II: Phase 2 Expansion CohortsExperimental Treatment1 Intervention
Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib
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Who is running the clinical trial?
Repare TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,048 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or have some restrictions but can still care for myself.I haven't had cancer treatment within the last 10 days or 5 half-lives.I haven't had major surgery in the last 4 weeks or minor surgery in the last week.I have previously been treated with an ATR or DNA-PK inhibitor.I can swallow and keep down pills.I have been diagnosed with MDS or AML.I am not receiving any other cancer treatments while on this study.I am 18 years old or older.My advanced cancer has not responded to standard treatments.I have brain metastases that are not under control and cause symptoms.I do not have any other active invasive cancers.I can provide tumor tissue or am willing to undergo a biopsy.My tumor has specific markers identified by a certified lab test.My blood and organs are functioning well according to my last check-up.I haven't had radiotherapy (except for comfort care) in the last 7 days.My high blood pressure is not under control.I don't have any health issues that would affect the study or stop me from fully participating.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ib Dose Escalation
- Group 2: Phase 2 Expansion Cohorts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any prior experiments that have investigated the use of RP-3500?
"RP-3500 has been studied since 2005 and so far, 80 trials have concluded. Currently there are 285 live studies taking place in Baltimore alone."
Answered by AI
Are there still vacancies available to participate in this trial?
"The information available on clinicaltrials.gov reveals that this medical trial is still seeking participants. This research project was first published on July 21st 2021 and modified most recently November 18th 2022."
Answered by AI
To what clinical symptoms is RP-3500 typically prescribed?
"RP-3500 is often used to treat advance directives, but it's also effective for malignant neoplasms of the ovary and primary peritoneal cancer. It can even be prescribed for hallucinations and somatic disorders."
Answered by AI
Is this medical test pioneering in nature?
"Since 2005, scientific research regarding RP-3500 has been ongoing. Initiated by AstraZeneca in the same year and involving 98 participants, this drug eventually obtained Phase 1 approval. Nowadays, 285 clinical trials are underway across 1638 municipalities and 62 nations."
Answered by AI
Are there any Canadian medical facilities that are currently administering this trial?
"This clinical experiment is taking place at Participating Site #1009 in Baltimore, Maryland, as well as the other seven sites listed. Two of these centres are located in Ann Arbor (Michigan) and Rochester (Minnesota)."
Answered by AI
How many participants are accepted into this investigation?
"In order to complete the trial, Roche Pharma AG needs 108 patients that satisfy their inclusion criteria. This will be done at Participating Site #1009 located in Baltimore and Participating Site #1015 based in Ann Arbor, Michigan."
Answered by AI
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