Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB



Status:Active, not recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:March 2014
End Date:March 2016

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A Phase 1 Study of [14C]- IXAZOMIB (MLN9708) to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphomas

This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients with
advanced solid tumors or lymphoma.


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
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