A Study of IXAZOMIB in Adult Patients With Lymphoma

NCT ID: NCT00893464

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-10-31

Brief Summary

This study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with lymphoma.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IXAZOMIB

Group Type: EXPERIMENTAL

IXAZOMIB

Intervention Type: DRUG

Patients will be administered IXAZOMIB by IV on Days 1, 8, and 15 of a 28-day cycle. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Interventions

IXAZOMIB

Patients will be administered IXAZOMIB by IV on Days 1, 8, and 15 of a 28-day cycle. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients 18 years or older.

2. Eastern Cooperative Oncology Group performance status 0-2.

3. Patients must have a confirmed diagnosis of lymphoma that is relapsed and/or refractory after at least 2 prior chemotherapeutic regimens and for which no curative option exists. Patients with Waldenstrom's macroglobulinemia are not eligible for enrollment in this study. Patients with Hodgkin lymphoma are considered eligible for this study.

4. Suitable venous access for PK and pharmacodynamic evaluations.

5. Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.

Male patients who agree to to practice 2 effective methods of contraception or abstain from heterosexual intercourse.

6. Voluntary written consent must be obtained.

7. Adequate blood and chemistry values during the screening period:

• Absolute neutrophil count (ANC) ≥ 1,500/mm3; platelet count ≥ 100,000/mm3.
• Total bilirubin must be ≤ 1.5 × the upper limit of the normal range upper limit of normal (ULN).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5 × the upper limit of normal (ULN). AST and ALT may be elevated up to 5 times the upper limit of normal if their elevation can be reasonably ascribed to the presence of metastatic disease.
• Calculated creatinine clearance ≥ 30 mL/minute.

Exclusion Criteria

1. Peripheral neuropathy ≥ Grade 2.

2. Female patients who are lactating or have a positive serum pregnancy test during the screening period .

3. Major surgery within 14 days before the first dose of treatment.

4. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment.

5. Life-threatening illness unrelated to cancer.

6. Diarrhea > Grade 1 based on the NCI CTCAE categorization.

7. Systemic antineoplastic therapy/or radiotherapy within 21 days before the first dose of study treatment.

8. Systemic treatment with prohibited medications.

9. Patient has symptomatic brain metastases.

10. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or myocardial infarction within the past 6 months.

11. QTc > 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period.

12. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C positive.

13. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

14. Treatment with any investigational products within 28 days before the first dose of study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Tower Cancer Research Center

Beverly Hills, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Kansas University Medical Center

Westwood, Kansas, United States

Cornell University

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Wisconsin Madison

Madison, Wisconsin, United States

Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

U1111-1166-8981

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16002

Identifier Type: -

Identifier Source: org_study_id