Phase 1 Program

SCCA Clinical Studies: Phase 1 Program

Dose-Escalation Study of MLN9708 (C16001) (UW08039)
An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
Status Conditions Phase Study ID
Closed Advanced Non-Hematologic Malignancies
Non Small Cell Lung Cancer
Head and Neck Cancer
Soft Tissue Sarcoma
Prostate Cancer
Phase I (C16001) (UW08039)

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.

John Thompson, MD
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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:

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
Last Updated
March 09, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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