Neoplasms

Blood and Lymph Conditions

All Conditions

Digestive System Diseases

Hematologic Neoplasms

Liver Diseases

Hematologic Diseases

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Liver Extracts

Ixazomib

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Experimental: Arm 1 (Normal hepatic function) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 4 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle

Experimental: Arm 2 (Moderate hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 2.3 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle

Experimental: Arm 3 (Severe hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 1.5 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle

IXAZOMIB

Medical Monitor

This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.

Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction

A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) in Patients With Advanced Solid Tumors or Hematologic Malignancies With Varying Degrees of Liver Dysfunction

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).

Millennium Pharmaceuticals, Inc.

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..

Normal Hepatic Function (Ixazomib 4 mg)

Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.

Moderate Hepatic Impairment (Ixazomib 2.3 mg)

Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.

Severe Hepatic Impairment (Ixazomib 1.5 mg)

Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Other

Asian

Race/Ethnicity, Customized

Height

Weight

Solid tumor

Solid tumor includes colon, colorectal, endometrial, esophageal, gall bladder, head and neck, kidney, liver, melanoma, mesothelioma, non-small cell lung cancer, ovarian, pancreatic, prostate, rectal, and sarcoma. Other tumor includes cholangiocarcinoma, malignant fibrous histiocytoma, metastatic poorly differentiated squamous cell carcinoma of the pelvis, moderately differentiated adenocarcinoma compatible with intrahepatic cholangiocarcinoma, unknown primary with liver metastasis, and peritoneal adenocarcinoma.

Disease type at diagnosis

Months from initial diagnosis to first dose of ixazomib

All participants had prior antineoplastic therapy.

Participants with prior antineoplastic therapy

Had prior radiation

Had no prior radiation

Participant with prior radiation

Had prior surgery

Had no prior surgery

Participant with prior surgery

ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Participants who had a score of 0 or 1 were assessed.

Baseline Eastern Cooperative Oncology Group (ECOG) performance status

Baseline total bilirubin

Baseline aspartate aminotransferase (AST)

The safety analysis population was defined as participants who received at least 1 dose of ixazomib.

Medical Director

The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.

Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib

Spots Global Cancer Trial Database for Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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