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

NCT03287271 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 170517
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Measured Via Adverse Events

  4 years

• Objective response rate (ORR)

  ORR by RECIST 1.1.

  4 years

Secondary Outcomes (4)

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

  4 years

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

  4 years

• progression free survival (PFS)

  4 years

• overall survival (OS)

  4 years

Study Arms (1)

Defactinib (VS-6063) +Carboplatin/Paclitaxel

EXPERIMENTAL

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Drug: VS-6063; Drug: Paclitaxel; Drug: Carboplatin

Interventions

VS-6063 DRUG

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.

Also known as: defactinib

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Paclitaxel DRUG

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.

Also known as: Taxol

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Carboplatin DRUG

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.

Also known as: Paraplatin

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael McHale: lead
• Verastem, Inc.: collaborator
• Nine Girls Ask: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92023, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

defactinib; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Michael McHale

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McHale, MD

CONTACT

(858) 822-6275; mtmchale@ucsd.edu

Alexandrea Cronin, MPH

CONTACT

(858) 822-3975; aocronin@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: September 19, 2017
• Study Start: February 6, 2018
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)