SNPMiner Trials (Home Page)
Report for Mutation Q28D
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain
This 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).
NCT02318407 Osteoarthritis Drug: AMG 403 Drug: Placebo MeSH:Osteoarthritis Osteoarthritis, Knee
HPO:Knee osteoarthritis Osteoarthritis
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 ---
Primary Outcomes
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 daysSecondary Outcomes
Description: 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 days2 Randomized Study of Romidepsin Versus the Combination of Romidepsin Plus Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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.
NCT03355768 Lymphoma, T-Cell, Peripheral Drug: Romidepsin Drug: Pralatrexate MeSH:Lymphoma Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell
HPO:Lymphoma T-cell lymphoma
The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. --- Q28D ---
Primary Outcomes
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 yearsSecondary Outcomes
Description: 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 months