Clinical trial NCT02924272: Ixazomib Rollover Study
Official title: An Open-Label, Rollover Protocol for Patients Previously Enrolled in Takeda-Sponsored Ixazomib Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lymphoma
Amyloidosis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2016-10-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 7 years
measure: Number of Participants With ≥ Grade 3 AEs
timeFrame: Up to 7 years
measure: Number of Participants With ≥ Grade 2 Peripheral Neuropathy
timeFrame: Up to 7 years
measure: Number of Participants With New Primary Malignancies
timeFrame: Up to 7 years
measure: Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug
timeFrame: Up to 7 years
measure: Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Hazard
country: United States
facility: Appalachian Regional Healthcare
state: Kentucky
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Leuven
country: Belgium
facility: UZ Leuven
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Hangzhou
country: China
facility: 1st Affiliated Hospital of Zhejiang University
city: Shanghai
country: China
facility: Shanghai Chang Zheng Hospital
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Athens
country: Greece
facility: University of Athens Medical School - Regional General Hospital Alexandra
city: Bunkyo-Ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Shibuya-Ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Chorzow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
state: Slaskie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp z o o
city: Singapore
country: Singapore
facility: National University Hospital
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca H. Clinico
city: San Sebastian
country: Spain
facility: Hospital Universitario de Donostia
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
state: Sodermanlands Lan
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: