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Trial record 1 of 1 for:    C16016
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Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01953783
First received: September 26, 2013
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients with advanced solid tumors or lymphoma.

Condition Intervention Phase
Advanced Solid Tumors Lymphoma Drug: IXAZOMIB Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of [14C]- IXAZOMIB (MLN9708) to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphomas

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum concentration (Cmax) [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    IXAZOMIB in plasma

  • Percent urinary recovery [ Time Frame: up to 35 days ]
  • IXAZOMIB excretion in urine [ Time Frame: up to 35 days ]
  • Percent fecal excretion [ Time Frame: up to 35 days ]
  • Percent of total radioactivity in urine and feces [ Time Frame: up to 35 days ]
  • First time to maximum concentration (Tmax) [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    IXAZOMIB in plasma

  • Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    IXAZOMIB in plasma


Secondary Outcome Measures:
  • Amount of metabolites in plasma [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    Metabolite profiles

  • Number of adverse events [ Time Frame: From first dose of study drug through 30 days after the last dose of study drug ]
  • Amount of metabolites in urine [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    Metabolite profiles

  • Amount of metabolites in feces [ Time Frame: Days 1-8; Days 14, 21, 28 and 35 ]
    Metabolite profiles


Enrollment: 7
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IXAZOMIB

Part A: Patients will receive a single dose of 4-mg [14C]- IXAZOMIB oral solution containing approximately 500 nCi of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, patients may be administered a single 4.0-mg capsule of IXAZOMIB. Patients will return to the clinic in the evening before Days 14, 21, 28, and 35 for a 24-hour overnight clinic visit.

Part B: Eligible patients from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Patients may receive IXAZOMIB capsules administered orally at a dose of 4.0-mg once weekly on Days 1, 8, and 15 of 28-day cycles. Patients will continue in this study until disease progression of unacceptable toxicity.

Drug: IXAZOMIB

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • 18 years or older
  • Histologic or cytologic diagnosis of advanced or metastatic solid tumor or lymphoma for which no standard, curative, or life-prolonging therapies exist or are effective
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Female patients who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time during the entire study through 90 days after the last dose of study drug OR agree to practice true abstinence
  • Male patients who agree to practice effective barrier contraception during the entire study and through 90 days after the last dose of study drug OR agree to practice true abstinence
  • Voluntary written consent
  • Suitable venous access for the conduct of blood sampling
  • Recovered from the reversible effects of prior anticancer therapy

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female patients who are lactating or breastfeeding or have a positive serum pregnancy test
  • Serious medical or psychiatric illness that could interfere with the study
  • Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug
  • Peripheral neuropathy > Grade 2
  • Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study drug
  • Symptomatic brain metastasis. Patients with brain metastases: must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy; and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs
  • Ongoing treatment with corticosteroids
  • Major surgery within the 14 days preceding the first dose of study drug
  • Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug
  • Life-threatening illness unrelated to cancer
  • Known hepatitis B surface antigen -positive, or known or suspected active hepatitis C infection or human immunodeficiency virus (HIV) positive
  • Diagnosed or treated for another malignancy within 2 years before the 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
  • Any cardiovascular condition specified in the study protocol
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB
  • History of urinary and/or fecal incontinence
  • Inability to comply with study procedures or visit schedule including the requirement for inpatient confinement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953783

Locations
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01953783     History of Changes
Other Study ID Numbers: C16016
Study First Received: September 26, 2013
Last Updated: January 14, 2016

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ixazomib
Glycine
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017