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ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287271
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : February 3, 2023
Sponsor:
Collaborators:
Verastem, Inc.
Nine Girls Ask
Information provided by (Responsible Party):
Michael McHale, University of California, San Diego

Study Description
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Brief Summary:
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether this regimen is safe. The study will also evaluate whether the regimen can reduce the amount of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not approved by the FDA for the treatment of cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: VS-6063 Drug: Paclitaxel Drug: Carboplatin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Defactinib (VS-6063) +Carboplatin/Paclitaxel Drug: VS-6063

Phase 1:

  • First 3 patient cohort: VS-6063 200 mg PO twice daily
  • IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,

Phase 2:

VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.

Other Name: defactinib

Drug: Paclitaxel

Phase 1:

  • First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
  • IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.

Phase 2:

Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.


Drug: Carboplatin

Phase 1:

  • First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
  • IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.

Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.


Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) [ Time Frame: 4 years ]
    Measured Via Adverse Events

  2. Objective response rate (ORR) [ Time Frame: 4 years ]
    ORR by RECIST 1.1.


Secondary Outcome Measures :
  1. To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) [ Time Frame: 4 years ]
    Measured Via Adverse Events

  2. To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire) [ Time Frame: 4 years ]
    Measured Via Questionnaire

  3. progression free survival (PFS) [ Time Frame: 4 years ]
    PFS by RECIST 1.1.

  4. overall survival (OS) [ Time Frame: 4 years ]
    OS by RECIST 1.1.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy.
  • Patients with the following histologic cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
  • Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, noncytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
  • 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.
  • May have received one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction.
  • Women of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.

Must have adequate:

  • Bone marrow function
  • Renal function
  • Hepatic function
  • Neurologic function
  • Recovered from effects of recent surgery, radiotherapy, or chemotherapy. All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to Grade 1.
  • Free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.

Exclusion Criteria:

  • Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Known second primary or prior malignancy diagnosed within 5 years of study start date (other than previously treated non-melanoma skin cancer).
  • Current treatment with chemotherapy or radiation therapy. Any prior therapy directed at the malignant tumor, including biologic and immunologic agents, must be discontinued at least three weeks prior to registration.
  • History of treatment with known kinase inhibiting agents.
  • History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease.
  • Patients who are pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287271


Contacts
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Contact: Michael McHale, MD (858) 822-6275 mtmchale@ucsd.edu
Contact: Alexandrea Cronin, MPH (858) 822-3975 aocronin@health.ucsd.edu

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92023
Contact: Alexandrea Cronin, MPH    858-822-3975    aocronin@health.ucsd.edu   
Sponsors and Collaborators
Michael McHale
Verastem, Inc.
Nine Girls Ask
Investigators
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Principal Investigator: Michael McHale University of California, San Diego
More Information
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Responsible Party: Michael McHale, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03287271    
Other Study ID Numbers: 170517
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael McHale, University of California, San Diego:
ovarian cancer
cancer
ovary
carboplatin
paclitaxel
 VS-6063
primary peritoneal carcinoma
fallopian tube
defactinib
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
 Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action