A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select druk combinations in adult patients with advanced or metastatic BRAF V600 colorectal cancer.
- Conditions
- advanced or metastatic BRAF V60010017991
- Registration Number
- NL-OMON52799
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
Patients must be >= 18 years of age.
ECOG performance status <= 1.
Patients must have a site of disease amenable to biopsy, and be a candidate for
tumor biopsy according to the treating institution*s guidelines.
All patients must have a BRAF V600 mutation confirmed by local assessment.
Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or
rectum with measurable disease as determined by RECIST v1.1
See for more details protocol section 5.1
Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of study drugs
Patients with CNS tumor involvement, unless > 2 weeks after completion of
CNS-therapy, stable with respect to CNS-involvement, not receiving steroids or
on stable dose of < 10 mg/day for two weeks.
Out of range laboratory values:
Hemoglobin (Hgb) < 9.0 g/dL
Platelets < 75 x 109/L
Serum total bilirubin > 1.5 x upper limit of normal (ULN),
Asparate aminotransferase (AST) > 3 x ULN
Alanine aminotransferase (ALT) > 3 x ULN
Serum creatinine > 1.5 x ULN OR Creatinine Clearance < 60 mL/min
Other exclusion criteria may apply, please see protocol section 5.2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence and severity of AEs and SAEs, including changes in laboratory values,<br /><br>vital signs, and ECGs<br /><br>Incidence and nature of DLTs in the first cycle (dose escalation only)<br /><br>Dose interruptions, reductions, and dose intensity</p><br>
- Secondary Outcome Measures
Name Time Method <p>Tumor MAPK pathway suppression (change from baseline) within combination<br /><br>treatment arms<br /><br>Tumor mutational changes throughout treatment course<br /><br>Tumor immune phenotyping within combination treatment arms (e.g. CD8, PD-L1)<br /><br>BOR per RECIST v1.1<br /><br>For individual investigational drug, compare the PK in combination regimen vs.<br /><br>as a single agent</p><br>