A Phase 1 Study of MLN9708 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: November 15, 2013
Last verified: November 2013

January 26, 2009
November 15, 2013
March 2009
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00830869 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Phase 1 Study of MLN9708 in Adult Patients With Advanced Nonhematologic Malignancies
An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies

This is an open-label, multicenter, phase 1, dose escalation study of MLN9708. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of MLN9708 administered intravenously in patients with nonhematologic malignancies.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Non-hematologic Malignancies
Drug: MLN9708

All patients will receive MLN9708 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.

Experimental: 1
MLN9708
Intervention: Drug: MLN9708
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
June 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00830869
C16001
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP