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An Open-Label, Dose-Escalation, Phase 1 Study of MLN9708, A Second-Generation Proteasome Inhibitor, in Adult Patients With Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

An Open-Label, Dose-Escalation, Phase 1 Study of MLN9708, A Second-Generation Proteasome Inhibitor, in Adult Patients With Lymphoma


Inclusion Criteria:



1. Male or female patients 18 years or older.

2. Eastern Cooperative Oncology Group performance status 0-2.

3. Patients must have a confirmed diagnosis of lymphoma that is relapsed and/or
refractory after at least 2 prior chemotherapeutic regimens and for which no curative
option exists. Patients with Waldenstrom's macroglobulinemia are not eligible for
enrollment in this study. Patients with Hodgkin lymphoma are considered eligible for
this study.

4. Suitable venous access for 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:

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 metastases.

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 or 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:

To determine the safety profile and maximum tolerated dose (MTD) of MLN9708 administered intravenously (IV) in patients with lymphoma

Outcome Time Frame:

1 year

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:

C16002

NCT ID:

NCT00893464

Start Date:

August 2009

Completion Date:

November 2013

Related Keywords:

  • Lymphoma
  • Lymphoma

Name

Location

Rocky Mountain Cancer CenterDenver, Colorado  80218
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Kansas University Medical CenterKansas City,, Kansas  66160-7390
Cornell UniversityNew York, New York  10021
University of Wisconsin MadisonMadison, Wisconsin  53792
Tower Cancer Research CenterBeverly Hills, California  90211