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Chemotherapy

RP-3500 for Solid Cancers

Phase 1 & 2
Waitlist Available
Led By Timothy A Yap, MBBS PhD FRCP
Research Sponsored by Repare Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resolution of all toxicities of prior treatment or surgery.
Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 1 year
Awards & highlights

Study Summary

This trial is testing a new drug, RP-3500, to see what dose is safe and effective for treating patients with solid tumors. The study will also look at the side effects of the drug and how it works in the body.

Who is the study for?
Adults with advanced solid tumors and specific ATR inhibitor-sensitizing mutations can join this trial. They must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and able to swallow pills. Participants need proper organ function, acceptable blood counts, and a negative pregnancy test if applicable. Contraception is required during the study and for six months after.Check my eligibility
What is being tested?
The trial tests RP-3500 (camonsertib) alone or combined with talazoparib or gemcitabine to find the safest high dose for Phase 2 trials. It will assess safety, how the body processes these drugs, their effects on tumors, and overall anti-tumor activity.See study design
What are the potential side effects?
Possible side effects include reactions related to drug tolerability such as fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to anemia or bleeding risks, potential liver dysfunction signs like jaundice or itchy skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from all side effects of my previous cancer treatments or surgeries.
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My cancer does not respond to standard treatments or I cannot tolerate them.
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My cancer's biomarker profile is available from a certified lab test.
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I can swallow and keep down pills.
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My organs are functioning well.
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I will use birth control during and for 6 months after the study, and won't donate sperm in this time.
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I am fully active or can carry out light work.
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I have signed and dated the consent form to participate in this study.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Dose limiting Toxicities (DLTs)
Safety and tolerability
To define the Maximum Tolerated Dose (MTD) which will then be used to inform and determine the Recommended Phase 2 Dose (RP2D) and schedule alone or in combination with talazoparib or gemcitabine
Secondary outcome measures
Assess CR+PR+SD (≥ 4 months) based on RECIST v1.1, confirmed CA-125 response by GCIG criteria, or PSA response based on PCWG3
Assess preliminary anti-tumor activity with Duration of Response (DOR) in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1).
Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: RP-3500 (camonsertib) with Talazoparib or GemcitabineExperimental Treatment3 Interventions
Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine
Group II: RP-3500 (camonsertib) aloneExperimental Treatment1 Intervention
Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration alone
Group III: Expansion cohorts with RP-3500 (camonsertib)Experimental Treatment1 Intervention
Phase 2: Expansion cohorts with RP-3500 (camonsertib)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Injection
2014
Completed Phase 3
~100
Talazoparib
2021
Completed Phase 2
~2740

Find a Location

Who is running the clinical trial?

Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,579 Total Patients Enrolled
Repare TherapeuticsLead Sponsor
8 Previous Clinical Trials
787 Total Patients Enrolled
Timothy A Yap, MBBS PhD FRCPPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Gemcitabine Injection [Gemzar] (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04497116 — Phase 1 & 2
Solid Tumors Research Study Groups: RP-3500 (camonsertib) alone, Expansion cohorts with RP-3500 (camonsertib), RP-3500 (camonsertib) with Talazoparib or Gemcitabine
Solid Tumors Clinical Trial 2023: Gemcitabine Injection [Gemzar] Highlights & Side Effects. Trial Name: NCT04497116 — Phase 1 & 2
Gemcitabine Injection [Gemzar] (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497116 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical maladies is RP-3500 a common remedy?

"RP-3500 has been approved for the management of urinary bladder, small cell lung cancer (SCLC), and head and neck carcinomas."

Answered by AI

Have any further investigations been conducted regarding RP-3500?

"Presently, there are 501 extant clinical trials studying RP-3500 with 137 of these studies in the third phase. Despite most of the investigations being located in Adelaide, South Australia; a total of 26822 medical centres across the globe have research programs dedicated to this drug."

Answered by AI

What is the full scope of locations where this experiment has been implemented?

"Nine medical centres are enrolling patients, among them being Participating Site 1006 in Boston, Participating Site 1002 in Toronto, and Participating Site 2001 in Providence. The other six locations can be found on the study's page."

Answered by AI

What goals are being sought after through the execution of this scientific experiment?

"The principal endpoint for this research is the safety and tolerability of RP-3500, which will be observed up to three months after treatment. Secondary outcomes include characterizing the medication's pharmacokinetic profile via AUC 0-inf; assessing target engagement by measuring immunohistochemistry biomarkers such as gH2AX in pre and post biopsies; ascertaining preliminary anti-tumor activity with an overall response rate in eligible advanced solid tumors according to CT/MRI RECIST 1.1 or CA-125/PSA GCIG PSWG criteria."

Answered by AI

Are applications for participation in this clinical investigation still being accepted?

"Affirmative, clinicaltrials.gov provides evidence that this medical trial is still recruiting participants as of the time of writing. The study was first introduced on July 22nd 2020 and most recently modified on September 9th 2022."

Answered by AI

How many subjects are being monitored for this experiment?

"To meet the requirements of this clinical trial, 451 suitable candidates need to be enrolled. Those wishing to partake may do so from Participating Site 1006 in Boston or Participating Site 1002 in Toronto."

Answered by AI
~0 spots leftby Mar 2024