Lymphoma, Non-Hodgkin, Multiple Myeloma, Solid Tumors
Conditions
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.
Interventions
DRUGSCH 727965
SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
DRUGAprepitant
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.
DRUGOndansetron
Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
DRUGDexamethasone
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed