Conditions: Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received MK-8776 10 mg/m\^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 2: Participants received MK-8776 20 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 3: Participants received MK-8776 40 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 4: Participants received MK-8776 80 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 5: Participants received MK-8776 112 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 6: Participants received MK-8776 80 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 7: Participants received MK-8776 112 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 8: Participants received MK-8776 150 mg/m\^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 9: Participants received MK-8776 200 mg given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.

Interventions: intervention 1: MK-8776 intervention 2: Gemcitabine
Intervention descriptions: intervention 1: IV infusion intervention 2: IV infusion

Protocol document: