What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as carboplatin and paclitaxel, often cause side effects including nausea, vomiting, fatigue, and neuropathy. Carboplatin can lead to myelosuppression, resulting in anemia, neutropenia, and thrombocytopenia. Paclitaxel is associated with hair loss, peripheral neuropathy, and hypersensitivity reactions. PARP inhibitors like olaparib can cause nausea, fatigue, anemia, and vomiting. These treatments aim to manage the disease but come with a range of potential adverse effects that patients should discuss with their healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ovarian cancer, including platinum-based chemotherapies like carboplatin and cisplatin, and taxanes such as paclitaxel. Additionally, PARP inhibitors like olaparib, niraparib, and rucaparib have been approved for maintenance therapy in recurrent, platinum-sensitive ovarian cancer. Bevacizumab, an angiogenesis inhibitor, is also approved for use in combination with chemotherapy. While FAK inhibitors like VS-6063 are still under investigation, other kinase inhibitors such as PI3K, AKT, and mTOR inhibitors (e.g., temsirolimus) have shown promise in clinical trials but are not yet standard treatments for ovarian cancer.

What other types of research exist?

Promising novel alternatives to VS-6063 for ovarian cancer patients include PARP inhibitors (e.g., olaparib, niraparib, rucaparib), immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), and antibody-drug conjugates (e.g., mirvetuximab soravtansine). These therapies have shown significant efficacy in clinical trials and are being actively investigated for their potential in treating ovarian cancer.

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Alkylating agents

VS-6063 + Chemotherapy for Ovarian Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Michael McHale

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have NOT received more than two total prior lines of cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Women of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception

Must not have

Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma

History of treatment with known kinase inhibiting agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Summary

This trial will test the safety and efficacy of the combination of VS-6063, carboplatin, and paclitaxel in patients with ovarian cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include those common to chemotherapy like nausea, fatigue, hair loss, low blood counts leading to increased infection risk or bleeding problems. The experimental drug may also cause unknown side effects due to its status as not FDA-approved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been treated with drugs that target enzymes.

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I have had issues like bleeding or holes in my stomach or intestines.

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I have not been diagnosed with any cancer other than non-melanoma skin cancer in the past 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)

Secondary outcome measures

To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)

To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)

overall survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Defactinib (VS-6063) +Carboplatin/PaclitaxelExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Paclitaxel

FDA approved

0 / 7Eligibility criteria met

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

Carboplatin and paclitaxel are standard treatments for ovarian cancer. Carboplatin works by causing DNA damage that prevents cancer cells from dividing, while paclitaxel stabilizes microtubules, inhibiting cell division. The investigational drug VS-6063 is a Focal Adhesion Kinase (FAK) inhibitor, which targets a protein involved in cancer cell survival, proliferation, and metastasis. By inhibiting FAK, VS-6063 aims to reduce cancer cell resistance to chemotherapy and limit tumor growth. Understanding these mechanisms is crucial for ovarian cancer patients as it helps in selecting effective treatment strategies and improving outcomes.