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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma; Solid Tumors; Lymphoma, Non-Hodgkin

Treatments: Drug: Aprepitant; Drug: Dexamethasone; Drug: SCH 727965; Drug: Ondansetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871910

P04630

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 5 patient groups

2 Hour SCH 727965 infusion

Experimental group

Description:

Participants treated with 2 hour SCH 727965 IV infusion

Treatment:

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

8 Hour SCH 727965 infusion

Experimental group

Description:

Participants treated with 8 hour SCH 727965 IV infusion.

Treatment:

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

24 Hour SCH 727965 infusion

Experimental group

Description:

Participants treated with 24 hour SCH 727965 IV infusion.

Treatment:

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

2 Hour SCH 727965 infusions plus aprepitant in Cycle 1

Experimental group

Description:

Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.

Treatment:

Drug: Ondansetron

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: Dexamethasone

Drug: Aprepitant

2 Hour SCH 727965 infusion plus aprepitant in Cycle 2

Experimental group

Description:

Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.

Treatment:

Drug: Ondansetron

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: SCH 727965

Drug: Dexamethasone

Drug: Aprepitant