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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06072781
Registration number
NCT06072781
Ethics application status
Date submitted
2/10/2023
Date registered
10/10/2023
Date last updated
30/08/2024
Titles & IDs
Public title
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
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Scientific title
A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)
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Secondary ID [1]
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GOG-3097
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Secondary ID [2]
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VS-6766-301
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Universal Trial Number (UTN)
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Trial acronym
RAMP 301
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low Grade Serous Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - avutometinib
Treatment: Drugs - Defactinib
Treatment: Drugs - Pegylated liposomal doxorubicin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Topotecan
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Experimental: avutometinib + defactinib - Avutometinib 3.2 mg, PO, twice weekly (eg, Monday/Thursday, Tuesday/Friday, or Wednesday/Saturday) for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.
Active comparator: Investigator Choice of Treatment (ICT) - Patients will receive one of the following therapies as determined by the Investigator:
* Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle.
* Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
* Topotecan: 4 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
* Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle.
* Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.
Treatment: Drugs: avutometinib
Avutometinib: administered orally
Treatment: Drugs: Defactinib
Defactinib: administered orally
Treatment: Drugs: Pegylated liposomal doxorubicin
administered intravenously
Treatment: Drugs: Paclitaxel
administered intravenously
Treatment: Drugs: Topotecan
administered intravenously
Treatment: Drugs: Letrozole
administered orally
Treatment: Drugs: Anastrozole
administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) per blinded independent central review (BICR)
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Assessment method [1]
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Confirmed overall response rate per RECIST 1.1 per blinded independent central review (BICR)
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Timepoint [1]
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Up to 24 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Progression Free Survival (PFS) per investigator assessment
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Assessment method [2]
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From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Objective response rate (ORR)
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Assessment method [3]
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From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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CR+PR+Stable disease
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [6]
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Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
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Timepoint [6]
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25 months
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Secondary outcome [7]
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Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites
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Assessment method [7]
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Area under plasma Concentration (AUC) 0 to t
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Timepoint [7]
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5 months
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Secondary outcome [8]
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Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites
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Assessment method [8]
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maximum plasma concentration
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Timepoint [8]
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5 months
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Secondary outcome [9]
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To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30).
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Assessment method [9]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of ovarian cancer patients. It is composed of 30 questions. An overall scoring range is from 0 to 100. A high scales score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. Quality of life measured by EORTC QLQ-C30. These are validated questionnaires to be answered by patients.
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Timepoint [9]
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24 months
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Secondary outcome [10]
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To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Ovarian Cancer module OV28 (QLQ-OV28).
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Assessment method [10]
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The EORTC QLQ-OV28 is a questionnaire to assess quality of life of ovarian cancer patients. It is composed of 28 questions. An overall scoring range is from 0 to 100. A high scales score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [10]
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24 months
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Eligibility
Key inclusion criteria
Patients may be eligible for inclusion in the study if they meet the following criteria:
1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
2. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
3. Measurable disease according to RECIST v1.1.
4. An Eastern Cooperative Group (ECOG) performance status = 1.
5. Adequate organ function
6. Adequate recovery from toxicities related to prior treatments.
7. For patients with reproductive potential, Agreement to use highly effective method of contraceptive.
8. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded from the study if they meet any of the following criteria:
1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
2. Co-existing high-grade ovarian cancer or another histology.
3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
4. History of prior malignancy with recurrence <3 years from the time of enrollment.
5. Major surgery within 4 weeks.
6. Symptomatic brain metastases or spinal cord compression.
7. An active skin disorder that has required systemic therapy within one year of signing informed consent.
8. History of medically significant rhabdomyolysis.
9. For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor.
10. Symptomatic bowel obstruction within 3 months.
11. Concurrent ocular disorders.
12. Concurrent heart disease or severe obstructive pulmonary disease.
13. Subjects with the inability to swallow oral medications.
14. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/02/2031
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Actual
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Sample size
Target
270
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
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Icon Cancer Centre Wesley - Auchenflower
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Recruitment hospital [3]
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Cancer Research South Australia - Adelaide
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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United States of America
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Illinois
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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North Carolina
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Ohio
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Canada
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Ontario
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Italy
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Milan
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Barcelona
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Spain
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Madrid
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Edinburgh
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London
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Manchester
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Verastem, Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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GOG Foundation
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
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Trial website
https://clinicaltrials.gov/study/NCT06072781
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rachel Grisham, MD
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Address
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GOG Foundation
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Contact person for public queries
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Verastem Call Center
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Address
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Phone
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781-292-4204
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06072781
Download to PDF