There are 2 clinical trials
This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.
The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. --- Q28D ---
Description: Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.
Measure: Progression Free Survival Time: up to 3 yearsDescription: Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Complete Response (CR) Time: up to 3 yearsDescription: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Duration of response (DOR) Time: up to 3 yearsDescription: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall survival (OS) Time: up to 3 yearsDescription: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall response rate (ORR) Time: up to 3 yearsDescription: TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Treatment Progression (TTP) Time: up to 3 yearsDescription: TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Relapse (TTR) Time: up to 3 yearsDescription: Describe the maximum number of cycles and planned dose intensity of all drugs in both arms in patients with R/R PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Maximum Number of Treatment Cycles Time: Up to 6 monthsThis is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).
In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4). --- Q28D ---
Description: Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
Measure: Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs Time: from 197 days to 211 daysDescription: serum concentrations and derived PK parameters of AMG 403
Measure: Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax Time: from 197 days to 211 days