Advanced Solid NeoplasmPhase 1NCT03486314

A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

A Phase 1 study testing Pevonedistat, Rifampin and Docetaxel in people with Advanced Solid Neoplasm, 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

The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Neoplasm
What is being tested?: Pevonedistat, Rifampin and Docetaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 4 sitesUnited States
Study dates: 13 Aug 2018to 28 Feb 2021
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

Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Expected survival of at least 3 months from the date of enrollment in the study.
Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Adequate organ functions (kidney, liver, cardiac, bone marrow).
Suitable venous access for the study-required blood sampling (including PK sampling).

Who cannot join

Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.
Active, uncontrolled infection or severe infectious disease.
Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection.
With significant heart or pulmonary disease.
Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.
Criteria for Continuation into Optional Part B:
To be eligible for Part B, participants must have completed Part A and be reassessed to determine if they meet the continuation criteria for Part B.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Emory University
Atlanta, Georgia, 30308
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-2013
Greenville Health System - Institute for Translational Oncology Research
Greenville, South Carolina, 29605

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors

The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.

Read the detailed description

The study will enroll approximately 20 participants. The study will be conducted in two Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment. In Part A, participants will be assigned to:

Pevonedistat 50 mg/m^2 + Rifampin

Eligible participants from Part A will continue treatment in optional Part B with pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus paclitaxel. The investigator will decide which SoC combination partner a participant will receive.

Pevonedistat 25 mg/m^2 + Docetaxel
Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 18 months. Participants will make a final visit to the clinic 30 days after receiving their last dose of study drug or before the start of subsequent therapy.

Conditions: Advanced Solid Neoplasm
Being tested: Pevonedistat, Rifampin, Docetaxel, Carboplatin, Paclitaxel
Keywords: Drug therapy

What participants receive

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

PevonedistatDrug
Also called MLN4924, TAK-924
Pevonedistat intravenous infusion.
RifampinDrug
Rifampin capsules.
DocetaxelDrug
Docetaxel intravenous infusion.
CarboplatinDrug
Carboplatin intravenous infusion.
PaclitaxelDrug
Paclitaxel intravenous infusion.

Study groups in NCT03486314
Study group	Role	What they receive
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg	Experimental	Pevonedistat 50 milligram per square meter (mg/m^2), intravenous infusion, once on Day 1 and 10 along with rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. After completion of Part A, participants had opportunity to continue into optional Part B. Receives: Drug: Pevonedistat; Drug: Rifampin
Part B: Pevonedistat	Experimental	Pevonedistat 25 mg/m^2 intravenously in combination with docetaxel 75 mg/m^2 or at 20 mg/m^2 in combination with carboplatin +paclitaxel 175 mg/m^2; pevonedistat was given in combination on Day 1 and as a single agent on Days 3 and 5 of each 21-day cycle. Participants were treated for up to 12 cycles or symptomatic deterioration or PD, treatment was discontinued for another reason, or until the study is stopped in Part B. The choice of combination partner (docetaxel or carboplatin + paclitaxel) was based on investigator discretion. If the sponsor and investigator determine that a participant would derive clinical benefit from continued treatment, the participant may remain on the current combination therapy or receive pevonedistat as a single agent beyond 12 cycles. Receives: Drug: Pevonedistat; Drug: Docetaxel; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary outcomes (4)

Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Measured: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
Best overall response was defined as participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target and non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter. PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study.
Measured: Up to Cycle 17 (end of treatment) (Cycle length =21 days)

Timeline

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

13 Aug 201828 Feb 2021

First posted3 Apr 2018
Study start13 Aug 2018
Primary completion10 May 2019
Study completion28 Feb 2021

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 NeoplasmStudies 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: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03486314
Sponsor's protocol ID: Pevonedistat-1015
Other IDs: U1111-1202-2144
Status last verified: Feb 2022
First submitted: 27 Mar 2018
Last updated: 18 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Zhou X, Vaishampayan U, Mahalingam D, Harvey RD, Chung KY, Sedarati F, Dong C, Faller DV, Venkatakrishnan K, Gupta N. Phase 1 study to evaluate the effects of rifampin on pharmacokinetics of pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1042-1050. doi: 10.1007/s10637-022-01286-8. Epub 2022 Aug 6.
PubMed 35932388

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 Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03486314
Acronym / sponsor ID: Pevonedistat-1015
Conditions: Advanced Solid Neoplasm
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 13 Aug 2018 (actual)
Primary completion: 10 May 2019 (actual)
Study completion: 28 Feb 2021 (actual)
First posted: 3 Apr 2018 (actual)
Results: Posted 18 Apr 2022

Clinical summary

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

The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.

Detailed description

Pevonedistat 50 mg/m^2 + Rifampin

Pevonedistat 25 mg/m^2 + Docetaxel
Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg	Experimental	Drug: Pevonedistat, Drug: RifampinPevonedistat 50 milligram per square meter (mg/m^2), intravenous infusion, once on Day 1 and 10 along with rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. After completion of Part A, participants had opportunity to continue into optional Part B.
Part B: Pevonedistat	Experimental	Drug: Pevonedistat, Drug: Docetaxel, Drug: Carboplatin, Drug: PaclitaxelPevonedistat 25 mg/m^2 intravenously in combination with docetaxel 75 mg/m^2 or at 20 mg/m^2 in combination with carboplatin +paclitaxel 175 mg/m^2; pevonedistat was given in combination on Day 1 and as a single agent on Days 3 and 5 of each 21-day cycle. Participants were treated for up to 12 cycles or symptomatic deterioration or PD, treatment was discontinued for another reason, or until the study is stopped in Part B. The choice of combination partner (docetaxel or carboplatin + paclitaxel) was based on investigator discretion. If the sponsor and investigator determine that a participant would derive clinical benefit from continued treatment, the participant may remain on the current combination therapy or receive pevonedistat as a single agent beyond 12 cycles.

Who may qualify

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

Key inclusion criteria (6 listed)

Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Expected survival of at least 3 months from the date of enrollment in the study.
Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Adequate organ functions (kidney, liver, cardiac, bone marrow).

Key exclusion criteria (8 listed)

Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.
Active, uncontrolled infection or severe infectious disease.
Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection.
With significant heart or pulmonary disease.

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
PevonedistatAlso: MLN4924, TAK-924Pevonedistat intravenous infusion.	Drug	Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg, Part B: Pevonedistat
RifampinRifampin capsules.	Drug	Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
DocetaxelDocetaxel intravenous infusion.	Drug	Part B: Pevonedistat
CarboplatinCarboplatin intravenous infusion.	Drug	Part B: Pevonedistat
PaclitaxelPaclitaxel intravenous infusion.	Drug	Part B: Pevonedistat

Primary outcome

Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.

4 secondary outcomes

Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
Time frame: Up to Cycle 17 (end of treatment) (Cycle length =21 days)

Results and safety

Results posted to the registry on 18 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg	20	17
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2	0	0
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2	0	0

Primary outcome: Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)

Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose. Least squares mean (90% Confidence Interval). Unit: ratio

Measure	Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg n = 17
Value	0.962 (0.792 to 1.168)

Population analysed: The pharmacokinetic (PK) evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.

Primary outcome: Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)

Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose. Least squares mean (90% Confidence Interval). Unit: ratio

Measure	Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg n = 17
Value	0.785 (0.684 to 0.901)

Population analysed: The PK-evaluable population was defined as all enrolled participants who a) received the protocol specified single pevonedistat dose in Part A; b) did not receive any excluded medications throughout the completion of Part A; and c) had sufficient concentration-time data to permit reliable estimation of PK parameters. As planned, this outcome measure was only assessed in Part A. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.

Primary outcome: Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10)

Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose. Least squares mean (90% Confidence Interval). Unit: ratio

Measure	Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg n = 17
Value	0.790 (0.692 to 0.902)

4 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 (From first dose of study drug up to Day 41 [Part A]; From first dose of study drug up to Cycle 17 Day 35 (Cycle length =21 days) [Part B]). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg	3 of 20 (15%)	11 of 20 (55%)	1 of 20
Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9
Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2	4 of 8 (50%)	8 of 8 (100%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35932388Zhou X, Vaishampayan U, Mahalingam D, Harvey RD, Chung KY, Sedarati F, Dong C, Faller DV, Venkatakrishnan K, Gupta N. Phase 1 study to evaluate the effects of rifampin on pharmacokinetics of pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1042-1050. doi: 10.1007/s10637-022-01286-8. Epub 2022 Aug 6.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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 Director 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 Pevonedistat, Rifampin and Docetaxel in people with Advanced Solid Neoplasm, 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 6 inclusion and 8 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 18 Apr 2022. 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 18 Apr 2022). 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: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) (time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose). The study lists 3 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 NCT03486314, 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 18 Apr 2022.