A Study of CA-4948 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03328078|
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Non Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma||Drug: CA-4948||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma|
|Actual Study Start Date :||December 28, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Part A: Dose-level cohorts with up to 6 patients each will be used to define the Maximum Tolerated Dose (MTD) for CA-4948.
Part B: The expansion phase of the study will be conducted in patients with Relapsed or Refractory Non-Hodgkin Lymphoma with and without MYD88 mutations. Patients will be treated with CA-4948 at the Recommended Phase 2 Dose (RP2D) or the MTD (or highest dose tested if MTD is not reached).
- The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: 12 months ]Toxicity will be graded and recorded according to the NCI CTCAE v4.03.
- Maximum tolerated dose (MTD) of CA-4948 measured by dose-limiting toxicities (DLTs) [ Time Frame: 12 months ]MTD determined by the highest dose level studied at which fewer than 2 out of 6 subjects (<33%) experience a dose limiting toxicity
- Recommended Phase 2 Dose (RP2D) of CA-4948 based on overall tolerability data [ Time Frame: 12 months ]RP2D selected based on overall tolerability data from all patients treated at different dose levels and will not exceed the MTD.
- Pharmacokinetic (PK) profile of CA-4948 measured by AUC [ Time Frame: 24- 36 months ]Area Under the concentration-time curve (AUC)
- Pharmacokinetic (PK) profile of CA-4948 measured by Cmax [ Time Frame: 24- 36 months ]Maximum plasma concentration (Cmax)
- Pharmacokinetic (PK) profile of CA-4948 measured by Cmin [ Time Frame: 24- 36 months ]Trough plasma concentration (Cmin)
- Pharmacokinetic (PK) profile of CA-4948 measured by Tmax [ Time Frame: 24- 36 months ]Time to maximum plasma concentration (Tmax)
- Pharmacokinetic (PK) profile of CA-4948 measured by plasma terminal half-life [ Time Frame: 24- 36 months ]Plasma terminal elimination half-life (T 1/2)
- Preliminary anti-cancer activity of CA-4948 based on Revised Response Criteria for Malignant Lymphoma or the consensus panel recommendations from the Sixth International Workshop on WM [ Time Frame: 24- 36 months ]Non-Hodgkin Lymphoma (NHL) patients other than Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma (WM/LPL) patients assessed by Revised Response Criteria for Malignant Lymphoma; WM/LPL patients assessed by the consensus panel recommendations from the Sixth International Workshop on WM
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328078
|Contact: David Tuck, MDemail@example.com|
|United States, Nebraska|
|Fred and Pamela Buffett Cancer Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98104|