Verastem Call Center

CONTACT

Luke Chung, MD

CONTACT

Lead Sponsor

Verastem, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Histopathology confirmed metastatic CRC
•Measurable disease per RECIST 1.1
•Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
•ECOG PS=0 or 1
•2L+ patients:
•Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
•Have documented disease progression during or following their most recent prior line of therapy
•Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.
•1L patients:
•Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.

•Have any other documented co-existing common RAS mutation(s)
•Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
•Major surgery within 4 weeks of first treatment dose
•Radiation therapy (RT) within 1 week of first treatment dose
•Receipt of prior direct RAS inhibitor
•Receipt of more than 1 investigational therapy
•Untreated or symptomatic CNS metastasis
•Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
•Receipt of PPI or H2 blocker within 5 days
•Inability to swallow oral medication