Ixazomib Rollover Study

• Sponsor: Takeda (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02924272
• Collaborator: Takeda Development Center Americas, Inc. (Industry)
• Enrollment: 31
• Locations: 24
• Arm: 1
• Anticipated Duration (Months): 84.5
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Lymphoma; Amyloidosis	Drug: Ixazomib	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies
• Actual Study Start Date: Dec 16, 2016
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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: MLN9708 Ninlaro

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Serious Adverse Events (SAEs) [Up to 5 years]

   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.

2. Number of Participants With ≥ Grade 3 AEs [Up to 5 years]

   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.

3. Number of Participants With ≥ Grade 2 Peripheral Neuropathy [Up to 5 years]

4. Number of Participants With New Primary Malignancies [Up to 5 years]

5. Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug [Up to 5 years]

6. Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event [Up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. The parent study is closed or planned to be closed; and

4. 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

5. 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).

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Appalachian Regional Healthcare	Hazard	Kentucky	United States	41701
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	UZ Leuven	Leuven		Belgium	3000
6	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 1X5
7	University Health Network	Toronto	Ontario	Canada	M5G 2M9
8	Peking University Third Hospital	Beijing	Beijing	China	100191
9	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
10	1st Affiliated Hospital of Zhejiang University	Hangzhou		China	310003
11	Shanghai Chang Zheng Hospital	Shanghai		China	200003
12	Laiko General Hospital of Athens	Athens	Attiki	Greece	115 27
13	University of Athens Medical School - Regional General Hospital Alexandra	Athens		Greece	11528
14	Asan Medical Center - PPDS	Seoul		Korea, Republic of	5505
15	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzow	Slaskie	Poland	41-500
16	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Lodz		Poland	93-510
17	Centrum Onkologii Ziemi Lubelskiej	Lublin		Poland	20-090
18	MTZ Clinical Research Sp z o o	Warszawa		Poland	02-106
19	National University Hospital	Singapore		Singapore	119082
20	Complejo Asistencial Universitario de Salamanca H. Clinico	Salamanca		Spain	37007
21	Hospital Universitario de Donostia	San Sebastian		Spain	20014
22	Karolinska Universitetssjukhuset Huddinge	Stockholm	Sodermanlands Lan	Sweden
23	Skanes Universitetssjukhus Lund	Lund		Sweden	22185
24	Karolinska Universitetssjukhuset Solna	Stockholm		Sweden	SE-17176

Sponsors and Collaborators

• Takeda
• Takeda Development Center Americas, Inc.

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02924272
• Other Study ID Numbers: C16027; U1111-1184-2041; 2016-001681-28
• First Posted: Oct 5, 2016
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Drug Therapy
• Additional relevant MeSH terms: Multiple Myeloma; Amyloidosis; Ixazomib

Study Results

No Results Posted as of Jan 11, 2022