Trials Sponsors Conditions Drugs Pricing

Conditions

Cervical Cancer Endometrioid Cancer High Grade Serous Ovarian Cancer Mucinous Ovarian Cancer Solid Tumor

Keywords

AvutometinibdefactinibVS-6766

Outcome Measures

Primary Outcomes (1)

Proportion of Patients with objective response rate
To evaluate the efficacy of Avutometinib (VS-6766) + defactinib in endometrioid, MOC, HGSOC and solid gynecological cancer patients with RAS/BRAF/NF1 mutations on confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to RECIST 1.1) as assessed by the investigator.
2 years

Secondary Outcomes (5)

Incidence of Adverse Events
2 years
Duration of Response
2 years

Study Arms (1)

Avutometinib (VS-6766) + Defactinib

EXPERIMENTAL

Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID).

Drug: Avutometinib (VS-6766) + defactinib

Interventions

Avutometinib (VS-6766) + defactinibDrug

Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID). Treatment will be for 3 weeks, followed by a 1-week rest period, in each 4-week (28 day) cycle.

Avutometinib (VS-6766) + Defactinib

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Avutometinib (VS-6766) + defactinib
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 99 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female subjects ≥ 18 years of age.
Histologically proven gynecological cancers (endometrioid, MOC, HGSOC and solid gynecological cancers) with mutated RAS, BRAF (type I, II, and/or III), NF-1 loss of function, and/or RAS activation.

Sponsors & Collaborators

Verastem, Inc.
Industrycollaborator
University of Oklahoma
Otherlead

Study Sites (4)

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

Robert Holloway, MDCONTACT407-303-2422 Robert.Holloway.MD@AdventHealth.com

Robert Holloway, MDPRINCIPAL INVESTIGATOR

Louisiana State University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Tara Castellano, MDCONTACT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

defactinib

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

Christina Washington, MD
OU Health Stephenson Cancer Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

SCC IIT Office

CONTACT

4052718777 SCC-IIT-Office@ouhsc.edu

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 23, 2022

Study Start

February 6, 2023

Actual (reported)

Primary Completion

You may not qualify if:

Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
Prior MEKi or RAFi exposure.
Low grade serous ovarian cancer (LGSOC).
History of prior malignancy with recurrence \<3 years from the time of enrollment. Subjects with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy with no evidence of disease recurrence for ≥1 year since completion of the appropriate therapy may be included. Subjects with other malignancies associated with very low risk of metastasis or death may be included upon discussion with the PI.
Subjects who are deemed in the opinion of their treating physician to be appropriate candidates for a debulking surgery. These subjects should preferentially receive surgery prior to consideration of trial therapy.
Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 1 week (7 days) of the first dose of study therapy.
Treatment with warfarin. Subjects on warfarin for DVT/PE can be converted to low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs).
Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy. See Table 14 and Table 15 for representative lists of CYP inhibitors and inducers. For additional guidance, see https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions-table-substrates-inhibitors-and-inducers.
Exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of the study. See Table 16 for a representative list of P-gp inhibitors and inducers.
Symptomatic brain metastases requiring steroids or other interventions. These metastases may manifest as altered mental status, persistent headaches, persistent nausea, focal weakness or numbness, and seizures. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 2 weeks prior to first dose of study therapy, and are neurologically stable, with no evidence of interim progression. Subjects with new asymptomatic CNS metastases detected during the screening period must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these subjects may then be eligible if all other criteria are met.
Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy.
Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection that is active and/or requires therapy.
Active skin disorder that has required systemic therapy within the past year.
History of rhabdomyolysis.
Concurrent ocular disorders:
+8 more criteria

A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Avutometinib (VS-6766) + Defactinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Avutometinib (VS-6766) + Defactinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations