At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas with available tumor sample
- ✓Evidence of disease documented by imaging (chest X-ray, CT abdomen, other scans as needed) within 28 days prior to randomization
- ✓Age ≥18 years
- ✓Negative pregnancy test at screening for women of childbearing potential
- ✕Hemoglobin <9.0 g/dL, neutrophil count <1.5×10⁹/L, or platelets <100×10⁹/L
- ✕Serum creatinine >1.5×ULN and/or creatinine clearance <60 mL/min
- ✕Total bilirubin >1.5×ULN; AST/ALT >2.5×ULN (or >5×ULN if liver involvement)
- ✕ECOG Performance Status >1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Randomized Trial of MEK Inhibitor MSC1936369B or Placebo Combined With Gemcitabine in Metastatic Pancreas Cancer Subjects
In Brief
A Phase 2 clinical trial evaluating Pimasertib, Gemcitabine, and 1 other intervention for Pancreatic Adenocarcinoma. Completed, enrolled 141 participants across 2 sites in 2 countries.
Detailed Summary
The research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts: Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.