NCT02943317

A Phase 1/1b Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Defactinib in Combination With Avelumab in Epithelial Ovarian Cancer

Terminated Phase 1 Last updated 28 April 2019

What this trial tests

Phase 1 trial testing Part A - VS-6063 in Epithelial Ovarian Cancer in 98 participants. Terminated before completion.

Timeline

1 October 2016

Primary endpoint
28 August 2018

28 December 2018

Quick facts

Lead sponsor	Verastem, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	1 October 2016
Primary completion	28 August 2018
Estimated completion	28 December 2018
Sites	5 locations across United States

Drugs / interventions tested

• Part A - VS-6063 — full drug profile →
• Part A - Avelumab — full drug profile →

Conditions studied

• Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →

Sponsor

Verastem, Inc. — full company profile →

Who can join

18 and older, female only, with Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants taking defactinib in combination with avelumab with Adverse Events as a Measure of Safety and Tolerability
  Time frame: Up to 90 days after last dose
• maximum tolerated dose (MTD) of defactinib in combination with avelumab (Part A)
  Time frame: From start of treatment to end of Cycle 1 (28 days)
• best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Part B)
  Time frame: From start of treatment, assessed up to 52 weeks

Sponsor's own description

This is a Phase 1/1b, open-label, multicenter, dose-escalation and dose expansion trial to evaluate the safety, efficacy, PK and PD of defactinib (VS-6063) in combination with avelumab in epithelial ovarian cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PD-1 and PD-L1 Checkpoint Signaling Inhibition for Cancer Immunotherapy: Mechanism, Combinations, and Clinical Outcome.
   Alsaab HO, Sau S, Alzhrani R, Tatiparti K, et al · · 2017 · cited 1206× · PMID 28878676 · DOI 10.3389/fphar.2017.00561
2. FAK in Cancer: From Mechanisms to Therapeutic Strategies.
   Chuang HH, Zhen YY, Tsai YC, Chuang CH, et al · · 2022 · cited 135× · PMID 35163650 · DOI 10.3390/ijms23031726
3. Hexokinase 2 Regulates Ovarian Cancer Cell Migration, Invasion and Stemness via FAK/ERK1/2/MMP9/NANOG/SOX9 Signaling Cascades.
   Siu MKY, Jiang YX, Wang JJ, Leung THY, et al · · 2019 · cited 105× · PMID 31212816 · DOI 10.3390/cancers11060813
4. Product review: avelumab, an anti-PD-L1 antibody.
   Collins JM, Gulley JL. · · 2019 · cited 62× · PMID 30481100 · DOI 10.1080/21645515.2018.1551671
5. Tumor-Associated Extracellular Matrix: How to Be a Potential Aide to Anti-tumor Immunotherapy?
   He Y, Liu T, Dai S, Xu Z, et al · · 2021 · cited 57× · PMID 34733848 · DOI 10.3389/fcell.2021.739161
6. The Crosstalk between FAK and Wnt Signaling Pathways in Cancer and Its Therapeutic Implication.
   Wörthmüller J, Rüegg C. · · 2020 · cited 45× · PMID 33266025 · DOI 10.3390/ijms21239107
7. Focal Adhesion Kinase Fine Tunes Multifaced Signals toward Breast Cancer Progression.
   Rigiracciolo DC, Cirillo F, Talia M, Muglia L, et al · · 2021 · cited 39× · PMID 33562737 · DOI 10.3390/cancers13040645
8. Role of Focal Adhesion Kinase in Small-Cell Lung Cancer and Its Potential as a Therapeutic Target.
   Aboubakar Nana F, Vanderputten M, Ocak S. · · 2019 · cited 35× · PMID 31671774 · DOI 10.3390/cancers11111683