| Title |
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) |
| Protocole ID |
RAMP-201 (ENGOT-ov60) |
| ClinicalTrials.gov ID |
NCT04625270 |
| Cancer Type(s) |
Ovary |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
VS-6766 seul ou en association avec defactinib |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Diane Provencher
|
| Coordinator |
Bonny Choy
514-890-8000 poste 24672
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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
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| |
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Groupe d'étude en oncologie du Québec