VS-6063 + Chemotherapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Michael McHale

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Michael McHale

Must not be taking: Kinase inhibitors

Disqualifiers: Platinum-refractory cancer, Recent malignancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for ovarian cancer that combines an experimental drug, VS-6063, with two approved chemotherapy drugs, carboplatin and paclitaxel. The goal is to see if this combination is safe and can reduce cancer cells. Patients will take VS-6063 by mouth and receive the other two drugs through infusions.

Will I have to stop taking my current medications?

The trial requires that any hormonal therapy directed at the tumor be stopped at least one week before joining, and any other cancer treatments, including biologic and immunologic agents, must be stopped at least three weeks before joining. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug combination VS-6063, Carboplatin, and Paclitaxel for ovarian cancer?

Research shows that combining paclitaxel with carboplatin is effective for treating ovarian cancer, especially in patients who are sensitive to platinum-based treatments. Paclitaxel has been found to be highly active in patients with platinum-resistant ovarian cancer, and dose-dense regimens of paclitaxel and carboplatin have improved survival rates. ^{1 2 3 4 5}

What safety data exists for the combination of VS-6063, carboplatin, and paclitaxel in treating ovarian cancer?

Carboplatin and paclitaxel have been studied together in ovarian cancer, showing that they can be safely administered, though they may cause side effects like neurotoxicity (nerve damage), alopecia (hair loss), and hypersensitivity (allergic reactions). The combination of docetaxel and carboplatin has been found to have a tolerable safety profile, with more myelosuppression (bone marrow suppression) but less neuropathy (nerve damage) compared to paclitaxel and carboplatin. There is no specific safety data available for VS-6063 in this context. ^{6 7 8 9 10}

What makes the drug VS-6063 + Chemotherapy unique for ovarian cancer?

The drug VS-6063 combined with chemotherapy is unique because it includes Defactinib, a novel agent that targets cancer stem cells, potentially enhancing the effectiveness of standard chemotherapy drugs like carboplatin and paclitaxel, which are commonly used in ovarian cancer treatment. ^{1 11 12 13 14}

Research Team

Michael McHale

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for women with certain types of ovarian cancer that came back or didn't go away after platinum-based chemo. They must have completed this treatment within the last 6 months and can't have had more than two chemo treatments for the recurrence. Participants need to be free from infections, recovered from past treatments, not pregnant, and using birth control.

Inclusion Criteria

I have had 2 or fewer chemotherapy treatments for my recurring cancer.

I am a woman who can have children, have a negative pregnancy test, and use birth control.

My cancer is one of the specified types, like serous or clear cell adenocarcinoma.

Exclusion Criteria

My ovarian, fallopian tube, or peritoneal cancer is not responding to platinum-based chemotherapy.

I am not on current cancer treatments and stopped any cancer-directed treatments at least 3 weeks ago.

Patients who are pregnant or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VS-6063 by mouth, as well as carboplatin and paclitaxel infusions

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Paclitaxel (Vinca alkaloids)
• VS-6063 (Kinase Inhibitor)

Trial Overview The ROCKIF Trial is testing a combination of VS-6063 (an experimental drug), carboplatin, and paclitaxel in treating ovarian cancer. Patients will take VS-6063 orally and receive infusions of carboplatin and paclitaxel to see if this regimen safely reduces cancer cells.

Participant Groups

Group I: Defactinib (VS-6063) +Carboplatin/Paclitaxel Experimental Treatment 3 Interventions

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Michael McHale

Lead Sponsor

Trials

1

Recruited

90+

Nine Girls Ask

Collaborator

Trials

1

Recruited

90+

Verastem, Inc.

Industry Sponsor

Trials

42

Recruited

2,800+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of ovarian cancer: current status. Ozols, RF.[2015]

References

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

Treatment of ovarian cancer: current status. [2015]

2. England pubmed.ncbi.nlm.nih.gov

A phase 2 study of intraperitoneal carboplatin plus intravenous dose-dense paclitaxel in front-line treatment of suboptimal residual ovarian cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A randomized phase II study of carboplatin plus pegylated liposomal doxorubicin versus carboplatin plus paclitaxel in platinum sensitive ovarian cancer patients: a Hellenic Cooperative Oncology Group study. [2021]

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

Second-line chemotherapy with gemcitabine and carboplatin in paclitaxel-pretreated, platinum-sensitive ovarian cancer patients. A Hellenic Cooperative Oncology Group Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A phase I-II trial of fixed-dose carboplatin and escalating paclitaxel in advanced ovarian cancer. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Weekly carboplatin in a frail elderly woman with advanced peritoneal carcinoma. [2013]

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

Role of docetaxel in the treatment of newly diagnosed advanced ovarian cancer. [2018]

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

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 States pubmed.ncbi.nlm.nih.gov

Docetaxel versus paclitaxel for adjuvant treatment of ovarian cancer: case-control analysis of toxicity. [2019]

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

Treatment of refractory and recurrent ovarian cancer. [2005]

12. England pubmed.ncbi.nlm.nih.gov

The integration of anthracyclines in the treatment of advanced ovarian cancer. [2018]

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

Chemotherapy of advanced ovarian cancer: current status and future directions. [2015]

14. England pubmed.ncbi.nlm.nih.gov

Challenges for chemotherapy in ovarian cancer. [2020]