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Tissue Adhesions

Oral defactinib (VS-6063) administered twice a day (BID) during a 21 day cycle.

Defactinib

Hagop Youssoufian, m

This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The purpose of this study is to assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).

Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies

A Phase I Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of VS-6063, a Focal Adhesion Kinase Inhibitor, in Japanese Subjects With Non-Hematologic Malignancies

A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.

The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03

The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.

PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.

Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1

Verastem, Inc.

The systematic method was through regular investigator assessment and regular laboratory testing.

Defactinib 200 mg Bid

Defactinib 400 mg Bid

Defactinib 600 mg Bid

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Lou Vaickus, MD, FACP/Chief Medical Officer

At least 1 TEAE (treatment emergent AE)

At least 1 TEAE related to study drug

Non-Lab TEAE with Severity ≥ Grade 3

Lab TEAE with Severity ≥ Grade 3

At least 1 Serious TEAE

Dose Interruptions

Dose Reductions

Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies

Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects.

Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine.

Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063).

200 mg bid (twice a day) po (by mouth) defactinib

Spots Global Cancer Trial Database for Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies

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