A Study of IXAZOMIB in Adult Patients With Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00893464
First received: May 4, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: IXAZOMIB
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Escalation, Phase 1 Study of IXAZOMIB (MLN9708), A Second-Generation Proteasome Inhibitor, in Adult Patients With Lymphoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To determine the safety profile and maximum tolerated dose (MTD) of IXAZOMIB administered intravenously (IV) in patients with lymphoma [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To determine the recommended phase 2 dose of IXAZOMIB in patients with lymphoma [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics (PK) of IV-administered IXAZOMIB in plasma and urine [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To characterize the pharmacodynamic effects of IV-administered IXAZOMIB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Investigators' assessments of disease response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IXAZOMIB Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893464

Locations
United States, California
Tower Cancer Research Center
Beverly Hills, California, United States, 90211
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Kansas
Kansas University Medical Center
Westwood, Kansas, United States, 66160
United States, New York
Cornell University
New York City, New York, United States, 10021
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00893464     History of Changes
Other Study ID Numbers: C16002
Study First Received: May 4, 2009
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014