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A Phase 1 Study of Oral MLN9708 to Assess Drug-Drug Interaction With Ketoconazole, Relative Bioavailability, Food Effect, Drug-Drug Interaction With Rifampin, and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma


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

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Trial Information

A Phase 1 Study of Oral MLN9708 to Assess Drug-Drug Interaction With Ketoconazole, Relative Bioavailability, Food Effect, Drug-Drug Interaction With Rifampin, and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma


Inclusion Criteria:



- Male or female patients 18 years or older

- Patients must have a diagnosis of histologically or cytologically confirmed
metastatic and/or advanced solid tumor malignancy or lymphoma for which no effective
standard treatment is available

- Female patients who are postmenopausal at least 1 year, OR surgically sterile, OR if
of childbearing potential, agree to practice 2 effective methods of contraception, at
the same time from the time of signing the consent form through 90 days after the
last dose of study drug, or agree to practice true abstinence

- Male patients, even if surgically sterilized, agree to practice effective barrier
contraception during the entire study treatment period and through 90 days after the
last dose of study drug OR agree to practice true abstinence

- Voluntary written informed consent

- Clinical laboratory values as specified in protocol

- Suitable venous access

- Recovered (ie, < Grade 1 toxicity or patient's baseline status) from the reversible
effects of prior anticancer therapy

Exclusion Criteria:

- Peripheral neuropathy > Grade 2 on clinical examination

- Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or
strong CYP3A inducers or use of Ginkgo biloboa or St. John's wort within 14 days
before the first dose of MLN9708

- Patient has symptomatic brain metastasis. Patients with brain metastases must: have
stable neurologic status following surgery or radiation for at least 2 weeks after
completion of the definitive therapy; AND be without neurologic dysfunction that
would confound the evaluation of neurologic and other adverse events

- Female patients who are pregnant or lactating

- Serious illness that could interfere with protocol completion

- Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior
allogeneic stem cell transplant at any time

- Prior treatment with rituximab or other unconjugated any antibody treatment within 42
days (21 days if there is clear evidence of progressive disease or immediate
treatment is mandated)

- Ongoing treatment with corticosteroids

- Radiotherapy within 21 days before the first dose of study drug

- Major surgery within 14 days before the first dose of study drug

- Infection requiring systemic antibiotic therapy or other serious infection within 14
days prior to first dose of study drug

- Life-threatening illness unrelated to cancer

- Known human immunodeficiency virus (HIV) positive, hepatitis B surface
antigen-positive, or suspected hepatitis C infection

- Diagnosis or treatment of another malignancy within 2 years preceding first dose, OR
previously diagnosed with another malignancy and have any evidence of residual
disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
not excluded if they have undergone complete resection

- Evidence of uncontrolled cardiovascular conditions

- QTc > 500 milliseconds on a 12-lead electrocardiogram (ECG)

- Known gastrointestinal disease or procedure that could interfere with the oral
absorption or tolerance of MLN9708 including difficulty swallowing capsules; diarrhea
> Grade 1 despite supportive therapy

- Patients with gastric achlorhydria

- Patients who have used any nicotine containing products within 14 days before the
first dose of study drug (Arm 1 and Arm 4 only)

- Treatment with any investigational products or systemic antineoplastic therapies
within 21 days before the first dose of MLN9708

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Arm 1: Ratio of geometric mean Cmax and AUC0-tlast of MLN9708 administered as Capsule B formulation with ketoconazole versus when administered as a single agent and 90% confidence intervals (CI)

Outcome Description:

Arm 1: Effect of ketoconazole on the single-dose pharmacokinetics of MLN9708 administered as Capsule B formulation

Outcome Time Frame:

Cycle 1: Days 1-28

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16009

NCT ID:

NCT01454076

Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Nonhematologic Malignancies
  • Lymphoma
  • Cmax: maximum plasma concentration
  • AUC0-tlast: time zero to the time of the last quantifiable concentration
  • Neoplasms
  • Lymphoma

Name

Location

University of UtahSalt Lake City, Utah  
IUPUIIndianapolis, Indiana  
Mary Crowley Cancer Research CentersDallas, Texas  75201
San Diego Pacific Oncology & Hematology Assoc Inc.San Diego, California  92024
UCLA Hematology-Oncology Santa MonicaSanta Monica, California  90404