Ovarian CancerPhase 1/2NCT03287271
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
A Phase 1/2 study testing VS-6063, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Michael McHale at 1 site in United States.
Trial summary
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- VS-6063, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 12 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92023
About this study
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
Read the detailed 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.
- Conditions
- Ovarian Cancer
- Being tested
- VS-6063, Paclitaxel, Carboplatin
- Keywords
- ovarian cancer, cancer, ovary, carboplatin, paclitaxel, VS-6063, primary peritoneal carcinoma, fallopian tube, defactinib
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-6063Drug
Also called defactinib
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.
PaclitaxelDrug
Also called Taxol
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.
CarboplatinDrug
Also called Paraplatin
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.
| Study group | Role | What they receive |
|---|---|---|
| Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel | Experimental | Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel Receives: Drug: VS-6063; Drug: Paclitaxel; Drug: Carboplatin |
| Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel | Experimental | Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel Receives: Drug: VS-6063; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity
Safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Measured: 28 days
Objective Response Rate (ORR)
Measured: 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)
Measured: 4 years
To Describe Health-related Quality-of-life (QoL) Outcomes of Patients Receiving VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy. (Measured Via Questionnaire)
Measured: 4 years
Progression Free Survival (PFS)
Measured: 4 years
Overall Survival (OS)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start6 Feb 2018
- Primary completion30 Jul 2023
- Study completion12 Mar 2025
Why it stopped: Due to loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael McHale
- Sponsor type
- University, hospital or other
- Collaborators
- Verastem, Inc., Nine Girls Ask
- Responsible party
- Sponsor-investigator, Michael McHale, University of California, San Diego
- Investigators
- Michael McHale, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287271
- Sponsor's protocol ID
- 170517
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2017
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
- ClinicalTrials.gov ID
- NCT03287271
- Acronym / sponsor ID
- 170517
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, cancer, ovary, carboplatin, paclitaxel, VS-6063, primary peritoneal carcinoma, fallopian tube
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to loss of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Michael McHaleUniversity, hospital or other
- Collaborators
- Verastem, Inc., Nine Girls Ask
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel | Experimental | Drug: VS-6063, Drug: Paclitaxel, Drug: CarboplatinDefactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel |
| Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel | Experimental | Drug: VS-6063, Drug: Paclitaxel, Drug: CarboplatinDefactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VS-6063Also: defactinibPhase 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. | Drug | Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel, Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel |
| PaclitaxelAlso: TaxolPhase 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 | Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel, Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel |
| CarboplatinAlso: ParaplatinPhase 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. | Drug | Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel, Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel |
Primary outcome
Dose-Limiting Toxicity
Time frame: 28 days
Safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Objective Response Rate (ORR)
Time frame: 4 years
4 secondary outcomes
To Assess the Toxicity and Adverse Event Profile of VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy (Measured Via Adverse Events)
Time frame: 4 years
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
Progression Free Survival (PFS)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McHale principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VS-6063, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Michael McHale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.