Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer

Phase 1/2 Completed 141 enrolled EMD Serono Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2009-11-30
Primary completion: 2013-12-31
Completion: 2015-04-30

Publications

Van Cutsem E, Hidalgo M, Canon JL, Macarulla T, Bazin I, Poddubskaya E, Manojlovic N, Radenkovic D, Verslype C, Raymond E, Cubillo A, Schueler A, Zhao C, Hammel P. Phase I/II trial of pimasertib plus gemcitabine in patients with metastatic pancreatic cancer. Int J Cancer. 2018 Oct 15;143(8):2053-2064. doi: 10.1002/ijc.31603. Epub 2018 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimasertib	Small molecule	15 mg	Oral
Subject	Pimasertib	Small molecule	30 mg	Oral
Subject	Pimasertib	Small molecule	45 mg	Oral
Subject	Pimasertib	Small molecule	60 mg	Oral
Subject	Pimasertib	Small molecule	68 mg	Oral
Subject	Pimasertib	Small molecule	75 mg	Oral
Subject	Pimasertib	Small molecule	90 mg	Oral
Subject	Pimasertib	Small molecule	120 mg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer

Summary

Timeline

Publications

Drugs

Indications