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A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00830869
First received: January 26, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in patients with nonhematologic malignancies.


Condition Intervention Phase
Advanced Non-hematologic Malignancies
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 Advanced Nonhematologic Malignancies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Dose limiting toxicities, adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements. [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma PK parameters [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Blood pharmacodynamic parameters [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Disease response based on the investigator's assessment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics and pharmacodynamics in tumor tissue [ Time Frame: Day 1, Day 4 ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IXAZOMIB (MLN9708)
Drug: IXAZOMIB

All patients will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days.

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:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  1. Male or female patients 18 years or older
  2. Eastern Cooperative Oncology Group performance status 0-2
  3. A diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective. In the expanded cohort, enrollment will be limited to patients with a diagnosis of NSCLC, head and neck cancer (squamous cell cancer), soft tissue sarcoma, or prostate cancer
  4. Suitable venous access 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 clinical laboratory values during the screening period

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  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 metastasis
  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 and 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: NCT00830869

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Washington
University of Washington- Seattle Cancer Care
Seattle, Washington, United States, 98109
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
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: NCT00830869     History of Changes
Other Study ID Numbers: C16001
Study First Received: January 26, 2009
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014