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An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Nonhematologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Nonhematologic Malignancies

Thank you

Trial Information

An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Nonhematologic Malignancies


Inclusion Criteria:



- Male or female patients 18 years or older

- Eastern Cooperative Oncology Group performance status 0-2

- Patients must have a diagnosis of a nonhematologic malignancy for which standard
curative, life-prolonging, or palliative treatment does not exist or is no longer
effective.

- Expected survival longer than 6 weeks from enrollment in the study

- Radiographically or clinically evaluable tumor

- Suitable venous access for the conduct of blood sampling for MLN4924

- Tumor tissue that, in the opinion of the investigator, can be safely biopsied using a
core needle

- Male patients must use an appropriate method of barrier contraception

- Female patients must be postmenopausal, surgically sterilized, or willing to use
reliable methods of birth control

- Voluntary written consent

Exclusion Criteria:

- Pregnant or lactating

- Major surgery within 14 days prior to the first dose of study treatment

- Serious infection within 14 days prior to the first dose of study treatment

- Receiving antibiotic therapy within 14 days prior to the first dose of study
treatment

- Life-threatening illness unrelated to cancer

- Diarrhea that is greater than Grade 1 in severity

- Systemic antineoplastic therapy within 21 days preceding first dose of study
treatment

- Radiotherapy within 21 days preceding first dose of study treatment

- Prior treatment with radiation therapy involving ≥25% of the hematopoietically active
bone marrow

- CYP3A inducers within 14 days before the first dose of MLN4924. Moderate and strong
CYP3A inhibitors and CYP3A inducers are not permitted during the study.

- Clinically significant central nervous system metastases

- Absolute neutrophil count <1,500/mm3; platelet count <100,000/mm3

- Patients with a prothrombin time or aPTT > 1.5 x the upper limit of the normal range,
or with a history of a coagulopathy or bleeding disorder

- Ongoing anti-coagulant therapy that can not be held to permit tumor biopsy

- Calculated creatinine clearance <50 mL/minute

- Bilirubin >1.5 times the upper limit of normal; aspartate aminotransferase, alanine
aminotransferase, or alkaline phosphatase >2.5 times the upper limit of normal.

- Uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive
heart failure, angina, or myocardial infarction within the past 6 months

- Abnormalities on 12-lead electrocardiogram including, but not limited to, changes in
rhythm and intervals that in the opinion of the investigator are considered to be
clinically significant

- Known human immunodeficiency virus positive or hepatitis B surface antigen-positive
status, or known or suspected active hepatitis C infection

- Treatment with any investigational products within 28 days preceding the first dose
of study treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924

Outcome Time Frame:

Maximum duration of therapy for 12 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

C15001

NCT ID:

NCT00677170

Start Date:

April 2008

Completion Date:

December 2012

Related Keywords:

  • Advanced Nonhematologic Malignancies
  • Neoplasms

Name

Location

Institute for Drug DevelopmentSan Antonio, Texas  78245-3217
Emory University HospitalAtlanta, Georgia  30322
Cancer Therapy & Research Center at the UT Health Science CenterSan Antonio, Texas  78229