drugset / Trial / NCT01347866

Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

NCT01347866

Phase 1 Terminated 105 enrolled Pfizer
Non-randomizedOpen-labelBasic science

Summary

After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.

Timeline

Start
2011-10
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gedatolisib Small molecule 95 mg Intravenous
Subject Gedatolisib Small molecule 110 mg Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Mirdametinib Small molecule 2 mg Oral