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Alkylating agents
VS-6063 + Chemotherapy for Ovarian Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Michael McHale
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Women of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will test the safety and efficacy of the combination of VS-6063, carboplatin, and paclitaxel in patients with ovarian cancer.
Who is the study for?
This trial is for women with certain types of ovarian cancer that came back or didn't go away after platinum-based chemo. They must have completed this treatment within the last 6 months and can't have had more than two chemo treatments for the recurrence. Participants need to be free from infections, recovered from past treatments, not pregnant, and using birth control.Check my eligibility
What is being tested?
The ROCKIF Trial is testing a combination of VS-6063 (an experimental drug), carboplatin, and paclitaxel in treating ovarian cancer. Patients will take VS-6063 orally and receive infusions of carboplatin and paclitaxel to see if this regimen safely reduces cancer cells.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy like nausea, fatigue, hair loss, low blood counts leading to increased infection risk or bleeding problems. The experimental drug may also cause unknown side effects due to its status as not FDA-approved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 2 or fewer chemotherapy treatments for my recurring cancer.
Select...
I am a woman who can have children, have a negative pregnancy test, and use birth control.
Select...
My cancer is one of the specified types, like serous or clear cell adenocarcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Secondary outcome measures
To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)
overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Defactinib (VS-6063) +Carboplatin/PaclitaxelExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Nine Girls AskUNKNOWN
Michael McHaleLead Sponsor
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,508 Total Patients Enrolled
3 Trials studying Ovarian Cancer
351 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ovarian, fallopian tube, or peritoneal cancer is not responding to platinum-based chemotherapy.I am not on current cancer treatments and stopped any cancer-directed treatments at least 3 weeks ago.I have had 2 or fewer chemotherapy treatments for my recurring cancer.I am a woman who can have children, have a negative pregnancy test, and use birth control.I have been treated with drugs that target enzymes.My cancer is one of the specified types, like serous or clear cell adenocarcinoma.My ovarian, fallopian tube, or peritoneal cancer came back within 6 months after platinum chemotherapy.My bone marrow, kidneys, liver, and nervous system are functioning well.I have recovered from recent cancer treatments with no major side effects.I have had issues like bleeding or holes in my stomach or intestines.I stopped my hormone therapy for cancer at least a week ago.I have not been diagnosed with any cancer other than non-melanoma skin cancer in the past 5 years.I am not currently on antibiotics for an infection, except for a simple UTI.I have had one platinum-based chemotherapy treatment for my cancer.I have had one non-chemotherapy treatment for my recurring or persistent disease.
Research Study Groups:
This trial has the following groups:- Group 1: Defactinib (VS-6063) +Carboplatin/Paclitaxel
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is access to this research project currently available for participants?
"Indeed, current information on clinicaltrials.gov specifies that this research is actively recruiting participants. The study was first published on February 6th 2018 and was last modified January 23rd 2020; the investigators are hoping to recruit 90 people at a single location."
Answered by AI
What further investigations have been conducted regarding the effects of VS-6063?
"In total, 1182 studies are currently underway studying the therapeutic potential of VS-6063. Of those active investigations, 332 have progressed to Phase 3 and span 68069 locations with a majority located in Shanghai."
Answered by AI
How extensive is the scope of this experimental program?
"Correct. According to clinicaltrials.gov, this medical trial is actively seeking participants from a single location and 90 people in total. The study was first posted on February 6th 2018 with the most recent update occurring January 23rd 2020."
Answered by AI
What are the essential goals of this trial?
"The objectives of this 4 year trial are to gauge the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (as evaluated through adverse events), observe changes in health related quality-of-life among patients receiving treatment, document any toxicities that may arise from therapy, and record overall survival rates as per RECIST 1.1 standards."
Answered by AI
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