Ixazomib Rollover Study

An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma; Multiple Myeloma; Amyloidosis
• Intervention / Treatment: Drug: Ixazomib

Detailed Description

The drug being tested in this study is called ixazomib. This study will look at the long term safety profile of ixazomib in participants who have previously received and tolerated ixazomib in a Takeda-sponsored clinical study, and in the investigator's opinion and approved by the Takeda medical monitor, may benefit from continued ixazomib therapy.

The study will enroll approximately 250 patients.

All participants will receive ixazomib as a single agent or in combination with other study drugs at same dose and schedule that they were receiving in the parent study until they experience disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until ixazomib is available to the participant is transitioned to ixazomib/other therapy through commercial channels, including reimbursement for the participant's indication, whichever is sooner.

This multicenter, rollover study will be conducted worldwide. The overall time to participate in this study is up to 7 years. Participants will make multiple visits to the clinic, and a final visit after 30 days of last dose of study drug for a safety assessment.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network
    • Toronto, Ontario, Canada, M5G 1X5
      • Princess Margaret Cancer Centre
• China
  • Hangzhou, China, 310003
    • 1st Affiliated Hospital of Zhejiang University
  • Shanghai, China, 200003
    • Shanghai Chang Zheng Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
• Greece
  • Athens, Greece, 11528
    • University of Athens Medical School - Regional General Hospital Alexandra
  • Attiki
    • Athens, Attiki, Greece, 115 27
      • Laiko General Hospital of Athens
• Japan
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital
    • Shibuya-Ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 5505
    • Asan Medical Center - PPDS
• Poland
  • Lodz, Poland, 93-510
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp z o o
  • Slaskie
    • Chorzow, Slaskie, Poland, 41-500
      • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
• Singapore
  • Singapore, Singapore, 119082
    • National University Hospital
• Spain
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca H. Clinico
  • San Sebastian, Spain, 20014
    • Hospital Universitario de Donostia
• Sweden
  • Lund, Sweden, 22185
    • Skånes Universitetssjukhus Lund
  • Stockholm, Sweden, SE-17176
    • Karolinska Universitetssjukhuset Solna
  • Sodermanlands Lan
    • Stockholm, Sodermanlands Lan, Sweden
      • Karolinska Universitetssjukhuset Huddinge
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Appalachian Regional Healthcare
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee.

2. Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when:

   1. The parent study is closed or planned to be closed; and
   2. The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]); and
   3. In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply).
3. Agree to continue to practice contraceptive methods as outlined in the parent study.

Exclusion Criteria:

1. The participant meets any of the criteria for treatment discontinuation in the parent study.
2. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ixazomib; Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.

Drug: Ixazomib; Ixazomib Capsules; Other Names: Ninlaro; MLN9708

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs)	SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an Adverse Event [AE] in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. This refers to an AE that may not result in death, be immediately life threatening, or require hospitalization, but may be considered serious when, based on appropriate medical judgment, may jeopardize the participant, require medical or surgical intervention to prevent 1 of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.	Up to 5 years
Number of Participants With ≥ Grade 3 AEs	An 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.	Up to 5 years
Number of Participants With ≥ Grade 2 Peripheral Neuropathy		Up to 5 years
Number of Participants With New Primary Malignancies		Up to 5 years
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug		Up to 5 years
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event		Up to 5 years

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: Takeda Development Center Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2016
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Proteostasis Deficiencies; Neoplasms, Plasma Cell; Multiple Myeloma; Amyloidosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protease Inhibitors; Ixazomib
• Other Study ID Numbers: C16027; U1111-1184-2041 (Other Identifier: WHO); 2016-001681-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No