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SNPMiner 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
Conditions
  1. Osteoarthritis
Interventions
  1. Drug: AMG 403
  2. 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 days

Secondary 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 days

2 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
Conditions
  1. Lymphoma, T-Cell, Peripheral
Interventions
  1. Drug: Romidepsin
  2. 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 years

Secondary 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 years

Description: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Duration of response (DOR)

Time: up to 3 years

Description: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall survival (OS)

Time: up to 3 years

Description: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall response rate (ORR)

Time: up to 3 years

Description: 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 years

Description: 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 years

Description: 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


HPO Nodes