CPI-0209 + Carboplatin for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Lan G Coffman, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Lan Coffman

Must not be taking: Warfarin, Herbal supplements

Disqualifiers: Platinum-resistant disease, HIV, Active infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take warfarin or certain herbal supplements. Foods like grapefruit that affect drug metabolism must be avoided starting 7 days before the trial.

What data supports the effectiveness of the drug combination CPI-0209 and Carboplatin for ovarian cancer?

Carboplatin has been shown to be effective in treating ovarian cancer, with response rates similar to cisplatin but with fewer side effects. It is often used in combination with other drugs for better outcomes, and studies have shown it to be effective in both first-line and recurrent ovarian cancer treatments. ^{1 2 3 4 5}

Is the combination of CPI-0209 and Carboplatin safe for treating ovarian cancer?

Carboplatin, used in various studies for different cancers, generally shows mild side effects like nausea and more serious blood-related issues like low platelet counts (thrombocytopenia). It has been used safely in combination with other drugs, but specific safety data for CPI-0209 combined with Carboplatin is not available in the provided research. ^{6 7 8 9 10}

How is the drug CPI-0209 + Carboplatin unique for treating ovarian cancer?

The combination of CPI-0209 and Carboplatin is unique because it pairs a novel drug, CPI-0209, with Carboplatin, a well-established chemotherapy agent, potentially enhancing the treatment's effectiveness against ovarian cancer. While Carboplatin is known for its activity in ovarian cancer, CPI-0209 may offer a new mechanism of action that could improve outcomes, especially in cases where traditional treatments have been less effective. ^{3 10 11 12 13}

Research Team

Lan G Coffman, MD

Principal Investigator

UPMC Magee Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I had brain metastasis treated over 8 weeks ago, am off steroids for 4 weeks, and my condition is stable or improved.

I agree to use effective birth control or abstain from sex for 6 months after the study ends.

I've had platinum-based therapy and possibly bevacizumab or PARPi. I may have a BRCA mutation.

Exclusion Criteria

I haven't had major surgery in the last 2 weeks or still have major side effects from it.

I had radiotherapy recently and still experience side effects.

I have a history of HIV infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPI-0209 in combination with Carboplatin chemotherapy

24 months

Maintenance

Participants continue with CPI-0209 maintenance therapy to prolong disease-free interval

Up to 5.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5.5 years

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• CPI-0209 (Epigenetic Modulator)

Trial Overview 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.

Participant Groups

Group I: CPI-0209 (250 mg) + carboplatin Experimental Treatment 2 Interventions

CPI-0209: 250 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Group II: CPI-0209 (200 mg) + carboplatin Experimental Treatment 2 Interventions

CPI-0209: 200 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Group III: CPI-0209 (150 mg) + carboplatin Experimental Treatment 2 Interventions

CPI-0209: 150 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Group IV: CPI-0209 (100 mg) + carboplatin Experimental Treatment 2 Interventions

CPI-0209: 150 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Magee-Womens Research Institute / UPMC Magee Womens Hospital Pittsburgh, PA

Who Is Running the Clinical Trial?

Lan Coffman

Lead Sponsor

Trials

1

Patients Recruited

30+

MorphoSys AG

Industry Sponsor

Trials

27

Patients Recruited

6,600+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin in the treatment of carcinoma of the ovary: the National Cancer Institute of Canada experience. Ovarian Cancer Subcommittee. Swenerton, KD., Pater, JL.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of pemetrexed in combination with carboplatin in patients with recurrent ovarian or primary peritoneal cancer. Sehouli, J., Alvarez, AM., Manouchehrpour, S., et al.[2015]

In a study of 27 ovarian cancer patients treated with Carboplatin, only 19% (5 patients) showed an objective response to the treatment, indicating limited efficacy.

Drug resistance was noted during the first course of therapy, suggesting that Carboplatin may not be effective for all patients and highlighting the need for alternative treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of carboplatin in treating patients with advanced ovarian cancer]. Pawlicki, M., Koralewski, P.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin in the first-line chemotherapy of ovarian cancer. Alberts, DS., Canetta, R., Mason-Liddil, N.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin reinduction after taxane in patients with platinum-refractory epithelial ovarian cancer. Kavanagh, J., Tresukosol, D., Edwards, C., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin and recurrent childhood brain tumors. Allen, JC., Walker, R., Luks, E., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of carboplatin in patients with ovarian carcinoma: a National Cancer Institute of Canada Clinical Trials Group Study. Eisenhauer, EA., Swenerton, KD., Sturgeon, JF., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of cisplatin i.p. and carboplatin i.v. with G-CSF in patients with ovarian cancer. Adachi, S., Ito, K., Itani, Y., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of a dose-finding study of paclitaxel and carboplatin in patients with advanced non-small cell lung cancer. Scagliotti, GV., Crinó, L., Pozzi, E., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal carboplatin: rationale and experience. Speyer, JL., Sorich, J.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phase II study of carboplatin in ovarian cancer]. Kato, T., Nishimura, H., Yamabe, T., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal dosing with carboplatin. Ozols, RF.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. Markman, M., Kennedy, A., Webster, K., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Carboplatin in the treatment of carcinoma of the ovary: the National Cancer Institute of Canada experience. Ovarian Cancer Subcommittee. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A phase II trial of pemetrexed in combination with carboplatin in patients with recurrent ovarian or primary peritoneal cancer. [2015]

3. Poland pubmed.ncbi.nlm.nih.gov

[Role of carboplatin in treating patients with advanced ovarian cancer]. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Carboplatin in the first-line chemotherapy of ovarian cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Carboplatin reinduction after taxane in patients with platinum-refractory epithelial ovarian cancer. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Carboplatin and recurrent childhood brain tumors. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II study of carboplatin in patients with ovarian carcinoma: a National Cancer Institute of Canada Clinical Trials Group Study. [2013]

8. Greece pubmed.ncbi.nlm.nih.gov

A phase I study of cisplatin i.p. and carboplatin i.v. with G-CSF in patients with ovarian cancer. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Preliminary results of a dose-finding study of paclitaxel and carboplatin in patients with advanced non-small cell lung cancer. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Intraperitoneal carboplatin: rationale and experience. [2018]

11. Japan pubmed.ncbi.nlm.nih.gov

[Phase II study of carboplatin in ovarian cancer]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Optimal dosing with carboplatin. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. [2015]