Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

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.

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.

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.

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.

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.

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.

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.

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.

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.

MK-8776

Medical Director

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.

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

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s).

An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented.

An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented.

The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.

AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method.

The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.

The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.

Merck Sharp & Dohme LLC

The population consisted of all participants who received at least one dose of MK-8776.

Participants received MK-8776 10 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.

MK-8776 10mg/m^2+Gemcitabine 800mg/m^2

MK-8776 20mg/m^2+Gemcitabine 800mg/m^2

MK-8776 40mg/m^2+Gemcitabine 800mg/m^2

MK-8776 80mg/m^2+Gemcitabine 800mg/m^2

MK-8776 112mg/m^2+Gemcitabine 800mg/m^2

MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2

MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2

MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2

Participants received MK-8776 200 mg given as a flat dose 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.

MK-8776 200mg Flat Dose+Gemcitabine 1000mg/m^2

MK-8776 200mg+Gemcitabine 1000mg/m^2

Total

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

The population consisted of all participants who were evaluable for DLT assessment (i.e., completed Cycle 0 and Cycle 1).

Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)

Number of Participants Who Experienced an Adverse Event (AE)

Number of Participants Who Discontinued Study Treatment Due to an AE

Cycle 0 (n=3, 3, 7, 6, 7, 4, 8, 3, 2)

Cycle 1 (n=3, 3, 7, 5, 6, 4, 6, 1, 2)

The population consisted of all participants who received at least two cycles of study treatment.

MK-8776 Maximum Plasma Concentration (Cmax)

MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial