Know Cancer

or
forgot password

An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Non-hematologic Malignancies

Thank you

Trial Information

An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities, adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements.

Outcome Time Frame:

Up to 12 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16001

NCT ID:

NCT00830869

Start Date:

March 2009

Completion Date:

June 2012

Related Keywords:

  • Advanced Non-hematologic Malignancies
  • Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Duke UniversityDurham, North Carolina  27710
Emory UniversityAtlanta, Georgia  30322
Sarah Cannon Research InstituteNashville, Tennessee  37203
University of Washington- Seattle Cancer CareSeattle, Washington  98109