NCT02018874

A Phase Ib Study of the Safety, Tolerability and Efficacy of LY2780301 in Combination With Gemcitabine

A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different tumor types with molecular alterations. This may validate the anti-tumor activity of the LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.

Conditions

• Solid Tumors and Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	LY2780301	LY2780301 will be given orally Q.D. at different dose levels. Because of a favourable safety profile, the different dose levels will be as follow : * Dose level -1: 300 mg Q.D. * Dose level -0.5: 400 mg Q.D. * Dose level 1: 400 mg Q.D. * Dose level 1.5: 500 mg Q.D. * Dose level 2 : 500 mg Q.D.
DRUG	Gemcitabine	The dose level of Gemcitabine will be fixed (1000 mg/m2). Gemcitabine will be administered over a 30 minutes infusion.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-12-23
• Last updated: 2016-07-12

Locations

1 site across 1 country: France