Advanced Solid TumorsPhase 1NCT01912222

Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction

A Phase 1 study testing IXAZOMIB in people with Advanced Solid Tumors and Hematologic Malignancies, run by Millennium Pharmaceuticals, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors, Hematologic Malignancies
What is being tested?: IXAZOMIB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 4 sitesUnited States
Study dates: Aug 2013to Mar 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
Patients must have a diagnosis of an advanced malignant solid tumor or hematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
Total bilirubin and aspartate aminotransferase (AST) levels consistent with normal hepatic function (total bilirubin and AST ≤ the upper limit of normal), moderate hepatic impairment (total bilirubin > 1.5 to 3x the upper limit of normal with any AST level) or severe hepatic impairment (total bilirubin > 3x the upper limit of normal with any AST level)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
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

Show all 9Show fewer

Voluntary written consent
Suitable venous access for the conduct of blood sampling
Appropriate clinical laboratory values as specified in the protocol

Who cannot join

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
Use of any nicotine-containing products within 14 days before the first dose of study drug
Central Nervous System Involvement or 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
Female patients who are lactating or breastfeeding or have a positive serum pregnancy test
Serious medical or psychiatric illness that could interfere with participation in the study
Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug

Show all 18Show fewer

Systemic anticancer therapy within 14 days before the first dose of study drug
Exposure to nitrosoureas or mitomycin C within 6 weeks before the first dose of study drug
Treatment with therapeutic monoclonal antibodies or antibody-drug conjugates within 60 days before the first dose of study drug
Radiotherapy or 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
Severe CNS, pulmonary, or renal disease not related to the patient's cancer
Known human immunodeficiency virus (HIV) positive
Evidence of uncontrolled cardiovascular conditions
QTc > 500 milliseconds (msec) on a 12-lead ECG obtained during the Screening period
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB
Known allergy to the study medication, its analogues, or excipients in the formulation

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Fairway, Kansas
Study site
Houston, Texas

Other trials in United States

About this study

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

Conditions: Advanced Solid Tumors, Hematologic Malignancies
Being tested: IXAZOMIB
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IXAZOMIBDrug

Study groups in NCT01912222
Study group	Role	What they receive
IXAZOMIB Arm 1	Experimental	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 Receives: Drug: IXAZOMIB
IXAZOMIB Arm 2	Experimental	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 Receives: Drug: IXAZOMIB
IXAZOMIB Arm 3	Experimental	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 Receives: Drug: IXAZOMIB

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib
Measured: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Measured: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
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.
Measured: Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Measured: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
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).
Measured: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Mar 2015

First posted31 Jul 2013 (estimated)
Study startAug 2013
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01912222
Sponsor's protocol ID: C16018
Other IDs: U1111-1177-7929
Status last verified: Feb 2016
First submitted: 26 Jul 2013
Last updated: 2 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) in Patients With Advanced Solid Tumors or Hematologic Malignancies With Varying Degrees of Liver Dysfunction
ClinicalTrials.gov ID: NCT01912222
Acronym / sponsor ID: C16018
Conditions: Advanced Solid Tumors, Hematologic Malignancies
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 31 Jul 2013 (estimated)
Results: Posted 25 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
IXAZOMIB Arm 1	Experimental	Drug: IXAZOMIBExperimental: 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
IXAZOMIB Arm 2	Experimental	Drug: IXAZOMIBExperimental: 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
IXAZOMIB Arm 3	Experimental	Drug: IXAZOMIBExperimental: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

18 years or older
Patients must have a diagnosis of an advanced malignant solid tumor or hematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
Total bilirubin and aspartate aminotransferase (AST) levels consistent with normal hepatic function (total bilirubin and AST ≤ the upper limit of normal), moderate hepatic impairment (total bilirubin > 1.5 to 3x the upper limit of normal with any AST level) or severe hepatic impairment (total bilirubin > 3x the upper limit of normal with any AST level)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
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

Key exclusion criteria (18 listed)

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
Use of any nicotine-containing products within 14 days before the first dose of study drug
Central Nervous System Involvement or 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
Female patients who are lactating or breastfeeding or have a positive serum pregnancy test
Serious medical or psychiatric illness that could interfere with participation in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IXAZOMIB	Drug	IXAZOMIB Arm 1, IXAZOMIB Arm 2, IXAZOMIB Arm 3

Primary outcome

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
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])
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.
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
Time frame: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)
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).

Results and safety

Results posted to the registry on 25 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Hepatic Function (Ixazomib 4 mg)	13	12
Moderate Hepatic Impairment (Ixazomib 2.3 mg)	15	13
Severe Hepatic Impairment (Ixazomib 1.5 mg)	20	18

Primary outcome: 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

Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose. Geometric mean (Standard Deviation). Unit: nanogram*hours per milliliter (ng*hr/mL)

Measure	Normal Hepatic Function (Ixazomib 4 mg) n = 12	Moderate Hepatic Impairment (Ixazomib 2.3 mg) n = 10	Severe Hepatic Impairment (Ixazomib 1.5 mg) n = 11
Value	9.6476 (5.39885)	7.3292 (5.35269)	4.4383 (4.21266)

Population analysed: 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.

Primary outcome: Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib

Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	Normal Hepatic Function (Ixazomib 4 mg) n = 12	Moderate Hepatic Impairment (Ixazomib 2.3 mg) n = 13	Severe Hepatic Impairment (Ixazomib 1.5 mg) n = 18
Value	0.50893 (0.271928)	0.37245 (0.385113)	0.23176 (0.271358)

Primary outcome: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose. Median (Full Range). Unit: hours

Measure	Normal Hepatic Function (Ixazomib 4 mg) n = 12	Moderate Hepatic Impairment (Ixazomib 2.3 mg) n = 13	Severe Hepatic Impairment (Ixazomib 1.5 mg) n = 18
Value	0.950 (0.48 to 4.00)	1.500 (0.50 to 2.50)	1.205 (0.50 to 4.00)

Primary outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Time frame: Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles]). Number. Unit: participants

Measure	Normal Hepatic Function (Ixazomib 4 mg) n = 13	Moderate Hepatic Impairment (Ixazomib 2.3 mg) n = 15	Severe Hepatic Impairment (Ixazomib 1.5 mg) n = 20
TEAE	13	15	20
SAE	6	10	15

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

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Hepatic Function (Ixazomib 4 mg)	6 of 13 (46.2%)	12 of 13 (92.3%)	Not reported
Moderate Hepatic Impairment (Ixazomib 2.3 mg)	10 of 15 (66.7%)	14 of 15 (93.3%)	Not reported
Severe Hepatic Impairment (Ixazomib 1.5 mg)	15 of 20 (75%)	17 of 20 (85%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced Solid Tumors

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IXAZOMIB in people with Advanced Solid Tumors and Hematologic Malignancies, run by Millennium Pharmaceuticals, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01912222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.