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

Conditions

• Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LAM-002A — DRUG
  25 mg capsules or 50 mg capsules
• Rituximab — DRUG
  375 mg/m2 by vein
• Atezolizumab — DRUG
  1200 mg by vein

Study Details

This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.

Key Dates

Start date

Oct 31, 2015

Status verified

Aug 2024

Primary completion

Mar 9, 2020

Completion

Mar 30, 2023

Study Design

Enrollment

62 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Continuous monotherapy
  All patients will take LAM-002A two times daily by mouth every day until cancer progression or intolerability.
• Experimental: Intermittent monotherapy
  All patients will receive LAM-002A at escalating dose levels two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
• Experimental: LAM-002A + rituximab
  All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab 375 mg/m2 by vein every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions)
• Experimental: LAM-002A + atezolizumab
  All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability

Primary Outcome Measure

Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A [ Time Frame: 28 days ]

Locations (11)

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