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

Phase 1

Completed

• Conditions: Multiple Myeloma; Lymphoma, Non-Hodgkin; Solid Tumors
• Interventions: Drug: SCH 727965; Drug: Aprepitant; Drug: Ondansetron; Drug: Dexamethasone

• Registration Number: NCT00871910
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-11
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-30
• Primary Completion: 2010-02-22
• Study Completion: 2010-02-22
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 Hour SCH 727965 infusion	SCH 727965	Participants treated with 2 hour SCH 727965 IV infusion
8 Hour SCH 727965 infusion	SCH 727965	Participants treated with 8 hour SCH 727965 IV infusion.
24 Hour SCH 727965 infusion	SCH 727965	Participants treated with 24 hour SCH 727965 IV infusion.
2 Hour SCH 727965 infusions plus aprepitant in Cycle 1	SCH 727965	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
2 Hour SCH 727965 infusion plus aprepitant in Cycle 2	SCH 727965	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
2 Hour SCH 727965 infusions plus aprepitant in Cycle 1	Aprepitant	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
2 Hour SCH 727965 infusions plus aprepitant in Cycle 1	Dexamethasone	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
2 Hour SCH 727965 infusions plus aprepitant in Cycle 1	Ondansetron	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
2 Hour SCH 727965 infusion plus aprepitant in Cycle 2	Aprepitant	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
2 Hour SCH 727965 infusion plus aprepitant in Cycle 2	Ondansetron	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
2 Hour SCH 727965 infusion plus aprepitant in Cycle 2	Dexamethasone	Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity	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.	Cycle 1

Secondary Outcome Measures

Name	Time	Method
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.	Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2