Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

Phase 1CompletedNCT00871910

Merck Sharp & Dohme LLC81 enrolled

Overview

Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Lymphoma, Non-Hodgkin Multiple Myeloma

Interventions

SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)

SCH 727965DRUG

SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts

SCH 727965DRUG

SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts

SCH 727965DRUG

SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle

AprepitantDRUG

Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3.

OndansetronDRUG

Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.

DexamethasoneDRUG

Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>=18 years, either sex, any race. * Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma. * There must be no known standard therapy, or disease must be refractory to standard therapy. * Eastern Cooperative Oncology Group performance status of 0, 1, or 2. * Adequate hematologic, renal, and hepatic organ function and laboratory parameters. Exclusion Criteria: * Symptomatic brain metastases or primary central nervous system malignancy. * Previous radiation therapy to \>25% of the total bone marrow. * Previous treatment with SCH 727965. * Known HIV infection.

Outcomes

Primary Outcomes

Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity

Time frame: End of trial

In Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.

Time frame: Cycle 1

Secondary Outcomes

In Part 3, area under the plasma concentration versus time curve and maximum concentration of SCH 727965 administered as a 2 hour intravenous infusion with or without aprepitant in participants with advanced malignancies.

Time frame: Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2

Data from ClinicalTrials.gov

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