Ixazomib Rollover Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02924272

Enrollment

Registered

2016-10-05

Start date

2016-12-16

Completion date

2024-07-03

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Lymphoma, Multiple Myeloma

Keywords

Drug Therapy

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.

Interventions

DRUGIxazomib

Ixazomib Capsules

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With New Primary Malignancies	Up to 7 years	—
Number of Participants With Serious Adverse Events (SAEs)	Up to 7 years	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an 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.
Number of Participants With ≥ Grade 3 AEs	Up to 7 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 (e.g., 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. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE.
Number of Participants With ≥ Grade 2 Peripheral Neuropathy	Up to 7 years	Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated.
Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug	Up to 7 years	An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product.
Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event	Up to 7 years	An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported.

Countries

Belgium, Canada, China, Greece, Japan, Poland, Singapore, South Korea, Spain, Sweden, United States

Participant flow

Recruitment details

Participants took part in the study at various investigative sites globally from 16 December 2016 to 03 July 2024.

Pre-assignment details

Participants who had previously received and tolerated treatment in ixazomib parent 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 \[NCT03170882\], or C16047 \[NCT03439293\]), and in investigator's opinion could benefit from continued therapy were enrolled.

Participants by arm

Arm	Count
Ixazomib Monotherapy Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.	23
Ixazomib Combination Therapy Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.	9
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	0
Overall Study	Clinical Deterioration	1	0
Overall Study	Death	1	0
Overall Study	Progressive Disease	11	8
Overall Study	Reason Not Specified	1	0
Overall Study	Site Terminated by Sponsor	4	1
Overall Study	Withdrawal by Subject	2	0

Baseline characteristics

Characteristic	Ixazomib Monotherapy	Ixazomib Combination Therapy	Total
Age, Continuous	75.1 years STANDARD_DEVIATION 6.45	64.6 years STANDARD_DEVIATION 9.53	72.2 years STANDARD_DEVIATION 8.73
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	11 Participants	5 Participants	16 Participants
Sex: Female, Male Male	12 Participants	4 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 23	0 / 9
other Total, other adverse events	9 / 23	6 / 9
serious Total, serious adverse events	12 / 23	4 / 9

Outcome results

Primary

Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug

An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product.

Time frame: Up to 7 years