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RP-6306 Combination Therapy for Cancer
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial seeks to determine if a new drug is safe and effective for treating cancer when combined with standard care. It also looks for biomarkers that may predict whether people respond better to treatment.
Who is the study for?
Adults with advanced cancers like endometrial, NSCLC, ovarian carcinosarcoma, TNBC, PDAC, colorectal cancer or HER-2+ gastroesophageal cancer. They must have tried some treatments already (like platinum-based chemotherapy), be in good physical condition and expected to live at least 3 months. Specific genetic markers are required for some cohorts. Pregnant women and those with certain health conditions or previous hypersensitivity to study drugs can't join.Check my eligibility
What is being tested?
The trial is testing RP-6306's safety and effectiveness against various advanced cancers when combined with standard treatments such as Gemcitabine or FOLFIRI Protocol. It also examines if patients' biomarkers affect their response to the treatment compared to usual cancer care approaches.See study design
What are the potential side effects?
Potential side effects of RP-6306 and other drugs used in this trial may include reactions related to drug infusion, impact on blood cells leading to increased infection risk, fatigue, digestive issues due to oral medication absorption problems, and possibly organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate of RP-6306 in patients with selected cancers receiving standard agent
Secondary outcome measures
Explore the recommended dose of RP-6306
Number and severity of adverse events
Trial Design
3Treatment groups
Active Control
Group I: RP-6306 + TrastuzumabActive Control2 Interventions
Group II: RP-6306 + GemcitabineActive Control2 Interventions
Group III: RP-6306 + FOLFIRIActive Control2 Interventions
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,409 Total Patients Enrolled
Repare TherapeuticsIndustry Sponsor
8 Previous Clinical Trials
1,166 Total Patients Enrolled
Eric ChenStudy ChairUniversity Health Network, Princess Margaret Hospital, Toronto ON Canada
3 Previous Clinical Trials
255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with gemcitabine.My cancer has a TP53 mutation.My colorectal cancer is advanced, cannot be surgically removed, and cannot be cured.My cancer has a TP53 mutation.I have never been treated with gemcitabine.I am using a highly effective method of birth control.My tumor is HER-2 positive and has CCNE1 amplification.I am 18 years old or older.I am fully active or can carry out light work.I have had platinum-based chemotherapy but not gemcitabine for my condition.I have undergone standard treatments like chemotherapy and immunotherapy for my condition.I can take pills and don't have issues absorbing food or medicine.My cancer has a TP53 mutation.I cannot stop taking my proton pump inhibitors or certain other medications.I had radiation therapy but it ended at least 4 weeks ago.I have never been treated with gemcitabine.My cancer has a TP53 mutation.My cancer has a TP53 mutation.I have a tissue sample from my cancer and have agreed to its use.I have previously used WEE1 or PKMYT1 inhibitors.It's been over 3 weeks since my last major surgery and my wounds have healed.I do not have conditions that would make taking pills difficult.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer treated without spreading, or any cancer treated over 2 years ago with no current signs of disease.My cancer is advanced, cannot be surgically removed, and cannot be cured.My disease was confirmed by a doctor or through imaging within the last 3 weeks.I have high-grade serous ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.My cancer worsened during or soon after first-line platinum-based treatment.My cancer in the stomach or esophagus cannot be surgically removed and has no cure.I have had FOLFOX chemotherapy for my cancer either as initial treatment or after it came back within 6 months.I had FOLFIRINOX treatment and my cancer returned within 6 months after.I have had platinum-based chemotherapy before but never gemcitabine.I have recovered from side effects of my last cancer treatment.I do not have any serious illnesses or infections that would prevent me from following the study's requirements.My cancer has both KRAS and TP53 mutations.I have had platinum-based chemotherapy but not gemcitabine for my condition.I can receive FOLFIRI treatment and do not have two copies of the UGT1A1*28 gene variant.I have not used growth factors in the last 28 days and won't need them during the trial.My liver and kidney functions are within the required limits.I have had brain or spinal cancer but am stable and not on steroids after treatment.I am not on any other cancer treatments except for stable bone-targeted therapy.I have received at least 2 treatments for my advanced cancer.My heart is healthy, and I don't have serious lung, brain diseases, or infections.I have advanced or recurrent high-grade serous endometrial cancer that cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: RP-6306 + Trastuzumab
- Group 2: RP-6306 + Gemcitabine
- Group 3: RP-6306 + FOLFIRI
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.
What is the overall count of medical facilities conducting this experiment?
"Four clinical trial sites are offering this medical intervention; Kingston Health Sciences Centre in Kingston, Ottawa Hospital Research Institute in Ottawa, and University Health Network in Toronto among others."
Answered by AI
How many individuals are currently partaking in this research trial?
"Affirmative, the clinicaltrials.gov documents state that this medical experiment is actively recruiting participants. The study was first posted on April 17th 2023 and most recently modified on May 31st 2023; 78 enrollees are needed from 4 distinct sites."
Answered by AI
Has the combination of RP-6306 and FOLFIRI been authorized by the Food & Drug Administration?
"Considering the lack of prior clinical data indicating its efficacy, RP-6306+FOLFIRI was rated a 2 in our team's safety scale."
Answered by AI
Are there still openings for those interested in participating in this experiment?
"Affirmative, the information on clinicaltrials.gov declares that this trial is currently recruiting volunteers. It was first announced to the public on April 17th 2023 and has since been updated on May 31st 2023. The study requires 78 individuals between 4 different test sites."
Answered by AI
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