Advanced Solid TumorsPhase 1NCT01953783

Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB

A Phase 1 study testing IXAZOMIB in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site 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, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors, Lymphoma
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: 7 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2014to 9 Feb 2016
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

Each participant 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 participants 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 participants 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
Recovered from the reversible effects of prior anticancer therapy

Who cannot join

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Female participants 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 greater than (>) 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

Show all 17Show fewer

Symptomatic brain metastasis. Participants 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 adverse events (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. Participants 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 gastrointestinal (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

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Cleveland, Ohio

Other trials in United States

About this study

Official title: A Phase 1 Study of [ 14 C]-Ixazomib to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphoma

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

Conditions: Advanced Solid Tumors, Lymphoma
Being tested: IXAZOMIB
Medical subject headings: Lymphoma

What participants receive

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

IXAZOMIBDrug
Part A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21.
Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity.

Study groups in NCT01953783
Study group	Role	What they receive
IXAZOMIB	Experimental	Part A: Participants will receive a single dose of 4.1-milligram (mg) [14C]-IXAZOMIB oral solution containing approximately 500-nCurie (nCi) of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, participants may be administered a single 4.0-mg capsule of IXAZOMIB. Participants 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 participants from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Participants 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. Participants will continue in this study until disease progression or unacceptable toxicity. Receives: Drug: IXAZOMIB

What is being measured

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

Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib
Time to reach the maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib
AUC(0-312) is a measure of the area under the plasma concentration time-curve from time zero to 312 hrs post-dose for ixazomib.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose
Part A: Cmax: Maximum Observed Plasma Concentration of TRA
Maximum observed plasma concentration (Cmax) of TRA is the peak plasma concentration of TRA, obtained directly from the plasma TRA concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Tmax: Time to Reach the Cmax for TRA
Time to reach the maximum observed plasma concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the plasma TRA concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: AUC(0-816): Area Under the Plasma Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
AUC(0-816) is a measure of the area under the plasma concentration time-curve from time zero to 816 hrs post-dose for TRA.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
Part A: Cmax: Maximum Observed Whole Blood Concentration of TRA
Maximum observed whole blood concentration (Cmax) of a TRA is the peak whole blood concentration of TRA, obtained directly from the whole blood TRA concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Tmax: Time to Reach the Maximum Observed Whole Blood Concentration (Cmax) for TRA
Time to reach the maximum observed whole blood concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the whole blood TRA concentration-time curve.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: AUC(0-816): Area Under the Whole Blood Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
AUC(0-816) is a measure of the area under the whole blood concentration time-curve from time zero to 816 hrs post-dose for TRA.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
Part A: Cumulative Percentage of Ixazomib Dose Recovered in the Urine
Percentage of the ixazomib dose excreted unchanged in the urine from 0 to 168 hrs post-dose.
Measured: Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Feces
Percentage of the TRA dose excreted in feces from Day 1 to Day 35 of Part A
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Urine
Percentage of the TRA dose excreted in urine from Day 1 to Day 35 of Part A.
Measured: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Renal Clearance of Ixazomib
Renal clearance is the volume of plasma from which ixazomib is completely removed by the kidney in a given amount of time, calculated as the amount of ixazomib excreted in the urine divided by the area under the plasma ixazomib concentration-time curve.
Measured: Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose

Secondary outcomes (6)

Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma
The plasma samples were pooled for participants over 816 hrs post-dose, and data was analysed using the Hamilton method time-proportional pooling, and therefore the data is reported as "percent of total radioactivity in plasma" with measure type as "number" and measure dispersion as "Not applicable, NA".
Measured: Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Urine
The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled urine. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA".
Measured: Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Feces
The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled feces. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA".
Measured: Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Investigations System Organ Class for Laboratory Values
Measured: Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Vital Signs
Vital signs included oral body temperature, heart rate, and blood pressure.
Measured: Baseline up to Cycle 5 Day 25

Timeline

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

19 Mar 20149 Feb 2016

First posted1 Oct 2013 (estimated)
Study start19 Mar 2014
Primary completion17 Dec 2014
Study completion9 Feb 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01953783
Sponsor's protocol ID: C16016
Status last verified: Aug 2020
First submitted: 26 Sep 2013
Last updated: 26 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gupta N, Zhang S, Pusalkar S, Plesescu M, Chowdhury S, Hanley MJ, Wang B, Xia C, Zhang X, Venkatakrishnan K, Shepard DR. A phase I study to assess the mass balance, excretion, and pharmacokinetics of [14C]-ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2018 Jun;36(3):407-415. doi: 10.1007/s10637-017-0509-1. Epub 2017 Sep 21.
PubMed 28932928

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

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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of [ 14 C]-Ixazomib to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphoma
ClinicalTrials.gov ID: NCT01953783
Acronym / sponsor ID: C16016
Conditions: Advanced Solid Tumors, Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 19 Mar 2014 (actual)
Primary completion: 17 Dec 2014 (actual)
Study completion: 9 Feb 2016 (actual)
First posted: 1 Oct 2013 (estimated)
Results: Posted 26 Aug 2020

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IXAZOMIB	Experimental	Drug: IXAZOMIBPart A: Participants will receive a single dose of 4.1-milligram (mg) [14C]-IXAZOMIB oral solution containing approximately 500-nCurie (nCi) of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, participants may be administered a single 4.0-mg capsule of IXAZOMIB. Participants 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 participants from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Participants 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. Participants will continue in this study until disease progression or unacceptable toxicity.

Who may qualify

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

Key inclusion criteria (9 listed)

Each participant 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 participants 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 (17 listed)

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Female participants 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 greater than (>) Grade 2

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
IXAZOMIBPart A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21. Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity.	Drug	IXAZOMIB

Primary outcome

Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.
Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Time to reach the maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.
Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose
AUC(0-312) is a measure of the area under the plasma concentration time-curve from time zero to 312 hrs post-dose for ixazomib.
Part A: Cmax: Maximum Observed Plasma Concentration of TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Maximum observed plasma concentration (Cmax) of TRA is the peak plasma concentration of TRA, obtained directly from the plasma TRA concentration-time curve.
Part A: Tmax: Time to Reach the Cmax for TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Time to reach the maximum observed plasma concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the plasma TRA concentration-time curve.
Part A: AUC(0-816): Area Under the Plasma Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
AUC(0-816) is a measure of the area under the plasma concentration time-curve from time zero to 816 hrs post-dose for TRA.
Part A: Cmax: Maximum Observed Whole Blood Concentration of TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Maximum observed whole blood concentration (Cmax) of a TRA is the peak whole blood concentration of TRA, obtained directly from the whole blood TRA concentration-time curve.
Part A: Tmax: Time to Reach the Maximum Observed Whole Blood Concentration (Cmax) for TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Time to reach the maximum observed whole blood concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the whole blood TRA concentration-time curve.
Part A: AUC(0-816): Area Under the Whole Blood Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
AUC(0-816) is a measure of the area under the whole blood concentration time-curve from time zero to 816 hrs post-dose for TRA.
Part A: Cumulative Percentage of Ixazomib Dose Recovered in the Urine
Time frame: Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose
Percentage of the ixazomib dose excreted unchanged in the urine from 0 to 168 hrs post-dose.
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Feces
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Percentage of the TRA dose excreted in feces from Day 1 to Day 35 of Part A
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Urine
Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Percentage of the TRA dose excreted in urine from Day 1 to Day 35 of Part A.
Part A: Renal Clearance of Ixazomib
Time frame: Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose
Renal clearance is the volume of plasma from which ixazomib is completely removed by the kidney in a given amount of time, calculated as the amount of ixazomib excreted in the urine divided by the area under the plasma ixazomib concentration-time curve.

6 secondary outcomes

Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Urine
Time frame: Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Feces
Time frame: Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Investigations System Organ Class for Laboratory Values
Time frame: Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Cycle 5 Day 25

Results and safety

Results posted to the registry on 26 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ixazomib	7	5

Primary outcome: Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib

Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	Ixazomib n = 5
Value	89.06 (67.834)

Population analysed: Pharmacokinetic(PK)-evaluable population included all participants who received protocol-specified single\[14C\]-ixazomib dose(Part A), did not receive any excluded concomitant medications till completion(Part A), had sufficient concentration-time and total radioactivity(TRA)-time data to permit reliable estimation of PK parameters and mass balance.

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

Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose. Median (Full Range). Unit: hour (hr)

Measure	Ixazomib n = 5
Value	0.5000 (0.044721)

Population analysed: The PK-evaluable population included all participants who received the protocol-specified single \[14C\]-ixazomib dose in Part A, did not receive any excluded concomitant medications through the completion of Part A, and had sufficient concentration-time and TRA-time data to permit reliable estimation of PK parameters and mass balance.

Primary outcome: Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib

Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose. Geometric mean (Standard Deviation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Ixazomib n = 5
Value	1181 (600.53)

Primary outcome: Part A: Cmax: Maximum Observed Plasma Concentration of TRA

Time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose. Geometric mean (Standard Deviation). Unit: nanogram-equivalent per milliliter

Measure	Ixazomib n = 5
Value	78.80 (48.814)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Cycle 5 Day 45).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ixazomib	1 of 7 (14.3%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28932928Gupta N, Zhang S, Pusalkar S, Plesescu M, Chowdhury S, Hanley MJ, Wang B, Xia C, Zhang X, Venkatakrishnan K, Shepard DR. A phase I study to assess the mass balance, excretion, and pharmacokinetics of [14C]-ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2018 Jun;36(3):407-415. doi: 10.1007/s10637-017-0509-1. Epub 2017 Sep 21.

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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.

1 site 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 Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site 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 17 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 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 26 Aug 2020). 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?

Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib (time frame: Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose). The study lists 13 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 NCT01953783, which also lists 1 linked publication.

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 26 Aug 2020.