AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma

Phase 1

Completed

• Conditions: Post-transplant Lymphoproliferative Disorder; Prolymphocytic Leukemia; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Refractory Multiple Myeloma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Anaplastic Large Cell Lymphoma; Hepatosplenic T-cell Lymphoma
• Interventions: Other: Pharmacodynamic Studies; Drug: AR-42; Other: Fatigue Inventory; Other: Pharmacogenomic studies

• Registration Number: NCT01129193
• Lead Sponsor: Amir Mortazavi

Brief Summary

RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or lymphoma.

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the safety by estimating the maximum tolerated dose (MTD) and describe the dose limiting toxicity (DLT) of AR-42 administered orally three times weekly (Mon, Wed, and Fri preferred) each week for 3 weeks during each 28-day period to adults with advanced or recurrent chronic lymphocytic leukemia (CLL), lymphoma, or multiple myeloma (MM).

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetics of AR-42 in this patient population. II. To analyze patient samples for descriptive information regarding AR-42 pharmacodynamic changes in this patient population.

III. To obtain pilot data regarding efficacy at the MTD as measured by partial and complete responses in each disease subgroup during protocol expansion in stage III.

OUTLINE:

Patients receive oral AR-42 three times weekly on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for at least 30 days.

Study Timeline

• Study Start: 2010-05-04
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Primary Completion: 2017-01-07
• Study Completion: 2017-01-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I (Hematologic Malignancies)	Pharmacodynamic Studies	Patients will receive orally administered AR-42 three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).
Arm I (Hematologic Malignancies)	Pharmacogenomic studies	Patients will receive orally administered AR-42 three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).
Arm I (Hematologic Malignancies)	Fatigue Inventory	Patients will receive orally administered AR-42 three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).
Arm II (Solid Tumors)	AR-42	Patients will receive orally administered AR-42 three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).
Arm I (Hematologic Malignancies)	AR-42	Patients will receive orally administered AR-42 three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).

Primary Outcome Measures

Name	Time	Method
Adverse events described using the NCI CTCAE criteria	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Time to progression	Up to 3 years
Clinical benefit	Up to 3 years
Duration of response	Up to 3 years

Trial Locations

Locations (1)

The Ohio State University James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States