24 Participants Needed

RP-6306 + Chemotherapy for Ovarian and Uterine Cancer

(GyneRep Trial)

SL
Overseen ByStephanie Lheureux, MD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: University Health Network, Toronto
Must be taking: Carboplatin, Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking chemotherapy or small molecule antineoplastic agents at least 21 days before starting the study treatment. Additionally, you should not be on strong CYP3A inhibitors or inducers within 14 days prior to the first dose. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What safety information is available for the combination of RP-6306, carboplatin, and paclitaxel in treating ovarian and uterine cancer?

Carboplatin and paclitaxel have been studied for their safety in treating ovarian cancer, showing some risk of hypersensitivity reactions (allergic reactions) and blood-related side effects like neutropenia (low white blood cell count) and thrombocytopenia (low platelet count). The combination of albumin-bound paclitaxel (Abraxane) and carboplatin has a different safety profile, with a lower rate of severe neutropenia compared to solvent-based paclitaxel.12345

What makes the drug RP-6306 combined with chemotherapy unique for treating ovarian and uterine cancer?

The combination of RP-6306 with carboplatin and paclitaxel is unique because it explores a novel agent (RP-6306) alongside standard chemotherapy drugs, potentially offering a new approach for patients who may not respond to traditional treatments. This trial aims to enhance the effectiveness of existing chemotherapy by integrating a new compound, which could provide additional benefits for patients with advanced ovarian and uterine cancers.56789

What evidence supports the effectiveness of the drug combination RP-6306, carboplatin, and paclitaxel for ovarian and uterine cancer?

Research shows that combining paclitaxel and carboplatin is a standard and effective treatment for advanced ovarian cancer, with studies indicating significant activity and acceptable toxicity. Paclitaxel is particularly effective in patients resistant to platinum-based treatments, and the combination has been associated with improved quality of life.5691011

Who Is on the Research Team?

Dr. Stéphanie Lheureux | Bras DDP

Stephanie Lheureux

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for women over 18 with advanced or recurrent ovarian and uterine cancer that's TP53 mutated, who can take oral meds, have good organ function, are not pregnant, and agree to use contraception. Excluded are those with recent major surgery, life-threatening conditions, uncontrolled infections like HIV/Hepatitis B/C, severe liver impairment or heart disease.

Inclusion Criteria

My ovarian or uterine cancer is advanced, cannot be cured with existing treatments.
I have tissue samples available for genetic testing.
My organs are functioning well enough for the study.
See 12 more

Exclusion Criteria

I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.
I don't have any health issues that could affect the study's results or my participation.
I am not allergic to RP-6306, carboplatin, or paclitaxel, or I can take them with steroids.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) of RP-6306 in combination with carboplatin and paclitaxel

21-day cycles
Visits every 21 days

Dose Expansion

Further assess the safety and tolerability and determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel

21-day cycles
Visits every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Paclitaxel
  • RP-6306
Trial Overview The study tests RP-6306 combined with carboplatin and paclitaxel in patients. It aims to find the safest dose (MTD) and see how well it works (efficacy). The first part sets the dose; the second part expands on safety data and preliminary effectiveness.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part B - Dose ExpansionExperimental Treatment3 Interventions
Group II: Part A - Dose EscalationExperimental Treatment3 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

Cytoreductive surgery followed by platinum-based chemotherapy, particularly with carboplatin, remains the standard treatment for advanced epithelial ovarian cancer, but most patients are not cured, highlighting the need for improved therapies.
Paclitaxel, a novel agent effective in platinum-resistant ovarian cancer, is being tested in combination with platinum compounds in clinical trials for previously untreated patients, aiming to enhance treatment efficacy.
Treatment of ovarian cancer: current status.Ozols, RF.[2015]
In a study involving 247 patients with advanced ovarian cancer, both treatment regimens (standard carboplatin plus paclitaxel and alternating carboplatin/cisplatin plus paclitaxel) showed similar efficacy, with no significant differences in progression-free survival (PFS) or overall survival.
Both regimens were well tolerated, indicating that while the alternating regimen does not provide additional benefits, it is a safe option for patients.
Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study.Aravantinos, G., Fountzilas, G., Kosmidis, P., et al.[2022]
In a trial involving 59 women with advanced ovarian cancer, the combination of paclitaxel and carboplatin resulted in a high response rate of 72%, indicating effective treatment for this patient population.
Patients experienced significant improvements in quality of life during the outpatient treatment, with median survival times of 30.1 months for those with measurable disease, suggesting that this regimen is both effective and well-tolerated.
Outpatient taxol and carboplatin chemotherapy for suboptimally debulked epithelial carcinoma of the ovary results in improved quality of life: an Eastern Cooperative Oncology Group Phase II Study (E2E93).Schink, JC., Weller, E., Harris, LS., et al.[2015]

Citations

Treatment of ovarian cancer: current status. [2015]
Taxane/platinum/anthracycline combination therapy in advanced epithelial ovarian cancer. [2015]
Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study. [2022]
Outpatient taxol and carboplatin chemotherapy for suboptimally debulked epithelial carcinoma of the ovary results in improved quality of life: an Eastern Cooperative Oncology Group Phase II Study (E2E93). [2015]
Chemotherapy: Current drugs still have potential in advanced ovarian cancer. [2021]
Phase I and pharmacokinetic trial of carboplatin and albumin-bound paclitaxel, ABI-007 (Abraxane) on three treatment schedules in patients with solid tumors. [2018]
Docetaxel versus paclitaxel for adjuvant treatment of ovarian cancer: case-control analysis of toxicity. [2019]
Carboplatin and short-infusion paclitaxel in high-risk and advanced-stage ovarian carcinoma. [2015]
Incidence of Hypersensitivity Reactions to Carboplatin or Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With or Without BRCA1 or BRCA2 Mutations. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel poliglumex and carboplatin as first-line therapy in ovarian, peritoneal or fallopian tube cancer: a phase I and feasibility trial of the Gynecologic Oncology Group. [2021]
A phase I dose-finding study of a combination of pegylated liposomal doxorubicin (Doxil), carboplatin and paclitaxel in ovarian cancer. [2022]
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