NCT01830816

Brief Summary

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) parameters of ixazomib (MLN9708) in cancer participants with either normal renal function or severe renal impairment (RI), including participants with end-stage renal disease (ESRD).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2013

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 16, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

April 4, 2013

Results QC Date

November 17, 2017

Last Update Submit

March 8, 2019

Conditions

Multiple MyelomaAdvanced Solid Tumors

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

  • Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib

    Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

    Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

  • Unbound AUClast: Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib

    Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

Secondary Outcomes (3)

  • Number of Participants With Adverse Events

    From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)

  • Percentage of Participants With Overall Response (OR) in Relapsed/Refractory Multiple Myeloma (RRMM) Participants

    Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)

  • Duration of Response (DOR) in RRMM Participants

    Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)

Study Arms (3)

Normal Renal Function: Ixazomib

EXPERIMENTAL

In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Drug: Ixazomib

Severe Renal Impairment: Ixazomib

EXPERIMENTAL

In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Drug: Ixazomib

End-stage Renal Disease: Ixazomib

EXPERIMENTAL

In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Drug: Ixazomib

Interventions

IxazomibDRUG

Ixazomib capsules

Also known as: MLN9708
End-stage Renal Disease: IxazomibNormal Renal Function: IxazomibSevere Renal Impairment: Ixazomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants 18 years or older
  • Participants with multiple myeloma (MM) diagnosed according to standard criteria or participants with a diagnosis of an advanced malignant solid tumor for which standard, curative, or life prolonging treatment does not exist or is no longer effective. Participants with multiple myeloma must have had at least 1 prior therapy
  • A calculated creatinine clearance (CrCl) that meets entry criteria for enrollment (i.e., calculated CrCl either ≥ 90 mL/min for normal renal function or \< 30 mL/min for severe renal impairment)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception 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 through 90 after the last dose of study drug or agree to practice true abstinence
  • Voluntary written informed consent
  • Suitable venous access

You may not qualify if:

  • Female participants who are pregnant or lactating and breastfeeding
  • Failure to have recovered from clinically significant effects of prior chemotherapy (defined as toxicity greater than Grade 1 with the exception of alopecia)
  • Major surgery or radiotherapy within 14 days before study drug administration
  • Dexamethasone (or equivalent systemic steroid) higher than physiologic dosing within 7 days before study drug administration
  • Central nervous system involvement
  • Infection requiring IV antibiotic therapy or other serious infection within 14 days prior to first dose of study drug
  • Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of patients in whom amyloidosis has been documented as a complication of MM, who will be evaluated on a case-by-case basis for trial participation)
  • Systemic treatment with strong and moderate inhibitors of Cytochrome P1A2 (CYP1A2), strong and moderate inhibitors of Cytochrome P3A (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
  • Evidence of uncontrolled cardiovascular conditions
  • Ongoing or active infection, or known human immunodeficiency virus (HIV) positive
  • Comorbid systemic illness or psychiatric illness that could interfere with study completion
  • Known allergy to study medications
  • Inability to swallow oral medication or condition that could interfere with oral absorption or tolerance of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

University of Kansas Cancer Center, Clinical Research Center

Fairway, Kansas, 66205, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Medical Center

New York, New York, 31406, United States

Location

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research Centers Medical City

Dallas, Texas, 75201, United States

Location

Institute of Oncology Hematology Biomedical Research

Laredo, Texas, 78041, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ixazomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Monitor

    Millennium Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 12, 2013

Study Start

September 16, 2013

Primary Completion

March 3, 2015

Study Completion

November 18, 2016

Last Updated

June 10, 2019

Results First Posted

June 10, 2019

Record last verified: 2019-03

Locations

US(10)CA(1)