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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
Must not have
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects
Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, CPI-0209, combined with chemotherapy in patients with recurrent ovarian cancer. The goal is to see if CPI-0209 can make chemotherapy work better and prevent the cancer from returning by blocking resistance and spread.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had major surgery in the last 2 weeks or still have major side effects from it.
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I had radiotherapy recently and still experience side effects.
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I have a history of HIV infection.
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My cancer is considered to be of low aggressiveness.
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I have severe nerve damage.
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My liver disease is moderately to severely advanced.
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I am currently taking warfarin or a similar blood thinner.
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I do not have any severe health conditions that would make it unsafe for me to join the study.
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I am currently being treated for an infection.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) of CPI-0209
Secondary study objectives
Adverse Events by Grade per CTCAE v5.0
Overall Response Rate (ORR)
Progression-free Survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ovarian cancer include platinum-based chemotherapies like carboplatin, which induce DNA damage in cancer cells, and taxanes like paclitaxel, which disrupt cell division by stabilizing microtubules. PARP inhibitors, another class of treatment, target cancer cells with defective DNA repair mechanisms, particularly those with BRCA mutations, leading to cell death.
Targeted therapies, such as CPI-0209, often inhibit specific pathways critical for cancer cell survival and proliferation. These treatments are crucial for ovarian cancer patients as they exploit the unique vulnerabilities of cancer cells, improving treatment efficacy and patient outcomes.
The combination of CPI-0209 with carboplatin, as studied in clinical trials, aims to enhance the effectiveness of chemotherapy and provide sustained control of the disease through maintenance therapy.
Adjunct Histamine Blockers as Premedications to Prevent Carboplatin Hypersensitivity Reactions.Pharmaceutical management of ovarian cancer : current status.Intraperitoneal carboplatin-based chemotherapy for epithelial ovarian cancer.
Adjunct Histamine Blockers as Premedications to Prevent Carboplatin Hypersensitivity Reactions.Pharmaceutical management of ovarian cancer : current status.Intraperitoneal carboplatin-based chemotherapy for epithelial ovarian cancer.
Find a Location
Who is running the clinical trial?
MorphoSys AGIndustry Sponsor
26 Previous Clinical Trials
6,566 Total Patients Enrolled
Lan CoffmanLead Sponsor
National Cancer Institute (NCI)NIH
13,878 Previous Clinical Trials
41,013,019 Total Patients Enrolled
292 Trials studying Ovarian Cancer
76,948 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.
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