RECRUITING

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

Conditions

Ovarian Cancer cancer ovary carboplatin paclitaxel VS-6063 primary peritoneal carcinoma fallopian tube defactinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.

Official Title

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

Quick Facts

Study Start:2018-02-06

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03287271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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

Inclusion Criteria

Exclusion 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.
* 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.

* 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

Study Contact

Michael McHale, MD

CONTACT

(858) 822-6275

mtmchale@ucsd.edu

Alexandrea Cronin, MPH

CONTACT

(858) 822-3975

aocronin@health.ucsd.edu

Principal Investigator

Michael McHale

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University of California San Diego

San Diego, California, 92023

United States

Collaborators and Investigators

Sponsor: Michael McHale

Michael McHale, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-06

Study Completion Date2026-04

Study Record Updates

Study Start Date2018-02-06

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Ovarian Cancer