A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma

Phase 1

Completed

• Conditions: Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic

• Registration Number: NCT02594384
• Lead Sponsor: OrphAI Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Able to understand and comply with the protocol requirements and has signed the<br> informed consent document.<br><br> 2. Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma<br> (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal<br> zone lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic<br> lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has progressed and<br> for which standard curative measures do not exist or are no longer effective. Prior<br> therapy must have included a rituximab-based regimen.<br><br> 3. Patients with DLBCL: Cancer progression after transplant, or be unwilling, unable or<br> not an appropriate candidate for an autologous stem cell or bone marrow transplant<br><br> 4. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy<br> (defined as the presence of 1 or more lesions that measure at least 2.0 cm in the<br> longest dimension (as assessed radiographically)<br><br> 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.<br><br> 6. Adequate organ and marrow function.<br><br> 7. Able to swallow oral capsules without difficulty.<br><br> 8. Acceptable birth control.<br><br> 9. Women of childbearing potential : negative pregnancy test<br><br> 10. Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral<br> blood) for analysis of potential predictive biomarkers.<br><br>Exclusion Criteria:<br><br> 1. Patients with central nervous system (CNS) lymphoma are not eligible for the trial<br> unless the disease had been treated and the subject remains without symptoms with no<br> active CNS lymphoma.<br><br> 2. Not recovered from toxicity due to all prior therapies.<br><br> 3. Other uncontrolled significant illness.<br><br> 4. History of malabsorption or other gastrointestinal (GI) disease that may<br> significantly alter the absorption of LAM-002A<br><br> 5. Major surgery within 28 days prior to first dose of study drug.<br><br> 6. Past history of tuberculosis (TB) or active infection with TB, human<br> immunodeficiency virus (HIV), hepatitis B or hepatitis C.<br><br> 7. Lactation or breast feeding.<br><br> 8. Unable or unwilling to abide by the study protocol or cooperate fully with the<br> Investigator or designee.<br><br>This is a shortened list and additional criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of LAM-002A;Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A;Objective Response Rate