Clinical Trials

Multiple Phase 1 clinical trials sponsored by Verastem, Inc. evaluated VS-4718 (PND-1186) across various oncologic settings, including advanced or metastatic non-hematologic malignancies, advanced pancreatic cancer in combination with nab-paclitaxel and gemcitabine, and relapsed or refractory acute myeloid and B-cell acute lymphoblastic leukemias. All of these studies have since been either terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01849744 TERMINATED
Non Hematologic Cancers; Metastatic Cancer
Verastem, Inc.
2013-06 PHASE1
NCT02651727 TERMINATED
Pancreatic Cancer
Verastem, Inc.
2015-09 PHASE1
NCT02215629 WITHDRAWN
Relapsed or Refractory Acute Myeloid Leukemia; Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Verastem, Inc.
PHASE1
NCT01849744 Terminated
Non Hematologic Cancers|Metastatic Cancer
Verastem Inc.
2013-06 Phase 1
NCT02215629 Withdrawn
Relapsed or Refractory Acute Myeloid Leukemia|Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Verastem Inc.
Phase 1

(data from https://clinicaltrials.gov, updated on 2017-07-28)

Check the VS-4718 (PND-1186) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VS-4718 acts as a reversible and selective focal adhesion kinase (FAK) inhibitor with an IC50 of 1.5 nM, disrupting downstream signal transduction to selectively induce apoptosis in tumor cells. By suppressing FAK-dependent pro-survival signaling and promoting cell death, this mechanism targets tumor progression across studied clinical conditions such as metastatic non-hematologic cancers, pancreatic carcinoma, and refractory acute leukemias.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.