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

• Status: Completed
• Trial end date: 2010-02-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

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.