NCT00779584

A Dose-escalation Study of MK-8776 (SCH 900776) With and Without Gemcitabine in Participants With Solid Tumors or Lymphoma (MK-8776-002/P05248)

A Phase 1 Dose-Escalation Study of SCH 900776 as Monotherapy and in Combination With Gemcitabine in Subjects With Advanced Solid Tumors or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study of MK-8776 (SCH 900776) will evaluate its safety and tolerability when given as monotherapy or in combination with gemcitabine to participants with advanced solid tumors or lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of gemcitabine The recommended combination doses for a Phase 2 trial (combination-RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional participants may be studied at the combination-RP2D.

Conditions

• Hodgkin Disease
• Lymphoma, Non-Hodgkin
• Neoplasms

Interventions

Type	Name	Description
DRUG	MK-8776	IV infusion
DRUG	Gemcitabine	IV infusion

Timeline

• Start date: 2008-10-17
• Primary completion: 2011-05-28
• Completion: 2011-05-28
• First posted: 2008-10-24
• Last updated: 2018-08-27
• Results posted: 2017-06-20