Clinical Trials /

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

NCT03287271

Description:

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.

Related Conditions:
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Malignant Ovarian Mixed Epithelial Tumor
  • Ovarian Adenocarcinoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Primary Peritoneal Clear Cell Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Undifferentiated Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
  • Official Title: ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK

Clinical Trial IDs

  • ORG STUDY ID: 170417
  • NCT ID: NCT03287271

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
VS-6063defactinibDefactinib (VS-6063) +Carboplatin/Paclitaxel
PaclitaxelDefactinib (VS-6063) +Carboplatin/Paclitaxel
CarboplatinDefactinib (VS-6063) +Carboplatin/Paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Defactinib (VS-6063) +Carboplatin/PaclitaxelExperimental
  • VS-6063
  • Paclitaxel
  • Carboplatin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Time Frame:4 years
Safety Issue:
Description:Measured Via Adverse Events

Secondary Outcome Measures

Measure:To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Time Frame:4 years
Safety Issue:
Description:Measured Via Adverse Events
Measure: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
Safety Issue:
Description:Measured Via Questionnaire
Measure:progression free survival (PFS)
Time Frame:4 years
Safety Issue:
Description:PFS by RECIST 1.1.
Measure:overall survival (OS)
Time Frame:4 years
Safety Issue:
Description:OS by RECIST 1.1.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Michael McHale

Trial Keywords

  • ovarian cancer
  • cancer
  • ovary
  • carboplatin
  • paclitaxel
  • VS-6063
  • primary peritoneal carcinoma
  • fallopian tube
  • defactinib

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