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Alkylating agents
CPI-0209 + Carboplatin for Ovarian Cancer
Phase 1
Recruiting
Led By Lan Coffman, MD, PhD
Research Sponsored by Lan Coffman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treated CNS metastasis allowed if treatment is completed ≥8 weeks prior to enrollment. Patients must be asymptomatic off systemic corticosteroids for at least 4 weeks after completion of radiation therapy. CNS disease must be stable or regressed on repeat imaging performed at least 4 weeks after completion of therapy
In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 years
Awards & highlights
Study Summary
This trial tests a new drug combo to treat ovarian cancer that's stopped responding to typical chemo.
Who is the study for?
This trial is for women with ovarian cancer that has returned more than 6 months after platinum-based chemotherapy. They must be able to take oral medication, have a life expectancy of at least 3 months, and agree to use effective contraception. Exclusions include certain medical conditions, recent treatments or surgeries, and those not recovered from previous therapy side effects.Check my eligibility
What is being tested?
The study tests CPI-0209 combined with Carboplatin followed by maintenance CPI-0209 in patients with recurrent ovarian cancer who responded well previously to platinum-based treatment. The goal is to see if this combination helps control the cancer better than current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to CPI-0209, typical chemotherapy-related issues like nausea and fatigue from Carboplatin, as well as possible impacts on blood counts and organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had brain metastasis treated over 8 weeks ago, am off steroids for 4 weeks, and my condition is stable or improved.
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I have been on the same birth control pill for at least 3 months.
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I can care for myself and my doctor expects me to live at least 3 more months.
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I can swallow pills or liquid medicine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of CPI-0209
Secondary outcome measures
Adverse Events by Grade per CTCAE v5.0
Overall Response Rate (ORR)
Progression-free Survival (PFS)
Trial Design
3Treatment groups
Experimental Treatment
Group I: CPI-0209 (250 mg) + carboplatinExperimental Treatment2 Interventions
CPI-0209: 250 mg (oral dosing) carboplatin administered intravenously as per institutional standards
Group II: CPI-0209 (200 mg) + carboplatinExperimental Treatment2 Interventions
CPI-0209: 200 mg (oral dosing) carboplatin administered intravenously as per institutional standards
Group III: CPI-0209 (150 mg) + carboplatinExperimental Treatment2 Interventions
CPI-0209: 150 mg (oral dosing) carboplatin administered intravenously as per institutional standards
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
Find a Location
Who is running the clinical trial?
MorphoSys AGIndustry Sponsor
26 Previous Clinical Trials
6,630 Total Patients Enrolled
Lan CoffmanLead Sponsor
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
288 Trials studying Ovarian Cancer
73,832 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had brain metastasis treated over 8 weeks ago, am off steroids for 4 weeks, and my condition is stable or improved.I haven't had major surgery in the last 2 weeks or still have major side effects from it.I agree to use effective birth control or abstain from sex for 6 months after the study ends.I had radiotherapy recently and still experience side effects.I have a history of HIV infection.I've had platinum-based therapy and possibly bevacizumab or PARPi. I may have a BRCA mutation.My cancer is considered to be of low aggressiveness.I have been on the same birth control pill for at least 3 months.I can care for myself and my doctor expects me to live at least 3 more months.I can swallow pills or liquid medicine.I have a GI condition that could affect how my body absorbs medication.I have recovered from side effects of previous cancer treatments.I have severe nerve damage.My liver disease is moderately to severely advanced.Your disease has been shown to come back or get worse according to specific medical guidelines.My ovarian, fallopian, or peritoneal cancer has returned more than 6 months after my last platinum-based treatment.I am currently taking warfarin or a similar blood thinner.You are allergic to any of the ingredients in CPI-0209.I stopped taking herbal supplements at least 7 days before starting the study drug.I do not have any severe health conditions that would make it unsafe for me to join the study.My cancer got worse within 6 months after platinum-based chemotherapy.I haven't had cancer in the last 3 years, except for certain skin cancers or treated cervical cancer.I am currently being treated for an infection.I have stopped eating foods that strongly affect liver enzymes 7 days before starting the study drug.My blood tests show my organs are working well.
Research Study Groups:
This trial has the following groups:- Group 1: CPI-0209 (150 mg) + carboplatin
- Group 2: CPI-0209 (200 mg) + carboplatin
- Group 3: CPI-0209 (250 mg) + carboplatin
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.
Has the combination of CPI-0209 (150 mg) and carboplatin been acknowledged by the FDA?
"Our team at Power gave CPI-0209 (150 mg) plus carboplatin a rating of 1, as it is in the early stages of development and requires additional data to assess safety and efficacy."
Answered by AI
Are there any opportunities presently to enroll in this scientific experiment?
"At the moment, this medical experiment is not enrolling any participants. According to clinicaltrials.gov, it was originally made available on September 1st 2023 but has been inactive since July 3rd of the same year. Nevertheless, there are 1743 other trials that require enrolment presently."
Answered by AI
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