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A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation (RAMP-201)

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ClinicalTrials.gov Identifier: NCT04625270
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : March 20, 2023
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Information provided by (Responsible Party):
Verastem, Inc.

Study Description
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Brief Summary:
This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Condition or disease Intervention/treatment Phase
Low Grade Ovarian Serous Adenocarcinoma Ovarian Cancer Drug: avutometinib (VS-6766) Drug: avutometinib (VS-6766) and Defactinib Phase 2

Detailed Description:
This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
 Drug: avutometinib (VS-6766)
avutometinib (VS-6766) Monotherapy

Drug: avutometinib (VS-6766) and Defactinib
avutometinib(VS-6766) and Defactinib Combination
Other Name: avutometinib (VS-6766) and VS-6063
Experimental: Part B
To determine the efficacy of the optimal regimen identified from Part A
 Drug: avutometinib (VS-6766)
avutometinib (VS-6766) Monotherapy

Drug: avutometinib (VS-6766) and Defactinib
avutometinib(VS-6766) and Defactinib Combination
Other Name: avutometinib (VS-6766) and VS-6063


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]
    Confirmed overall response rate per RECIST 1.1

  2. Part B: To determine the efficacy of the optimal regimen identified from Part A [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]
    Confirmed overall response rate per RECIST 1.1


Secondary Outcome Measures :
  1. Overall Response Rate as assessed by Investigator [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]
    Proportioned subjects achieving a CR or PR as assess by the investigator

  2. Duration of Response (DOR) [ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months ]
    From time of first response to PD as assessed by the BIRC

  3. Disease Control Rate (DCR) [ Time Frame: Greater than or equal to 8 weeks ]
    CR+PR+stable disease

  4. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    From time of first dose of study intervention to PD or death for any cause

  5. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    From time of first dose of study intervention to death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven LGSOC (ovarian, peritoneal)
  • In Part A KRAS mutation, KRAS wt
  • Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive

Exclusion Criteria:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • Co-existing high-grade ovarian cancer or another histology
  • History of prior malignancy with recurrence <3 years from the time of enrollment
  • Major surgery within 4 weeks
  • Symptomatic brain metastases requiring steroids or other interventions
  • Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
  • For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
  • Active skin disorder that has required systemic therapy within the past year
  • History of rhabdomyolysis
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625270


Contacts
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Contact: Verastem Call Center 781-292-4204 clinicaltrials@verastem.com

Locations
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Sponsors and Collaborators
Verastem, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Investigators
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Principal Investigator: Susana Banerjee, MBBS,MA,PhD European Network of Gynaecological Oncological Trial Groups (ENGOT)
Principal Investigator: Rachel Grisham, MD GOG Foundation
Study Director: MD Verastem Verastem, Inc.
More Information
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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT04625270    
Other Study ID Numbers: VS-6766-201
GOG-3052 ( Other Identifier: The GOG Foundation, Inc. )
ENGOT-ov60 ( Other Identifier: ENGOT )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verastem, Inc.:
Low Grade Serous Ovarian Cancer
KRAS, KRAS wt
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
 Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous