The aim of the study is to provide patients with certain kinds of cancer continued access to the same drug they have received in a previous study, if they have benefited from the use of the drug.

Phase 1

• Conditions: Patients who previously received and tolerated a defined study regimen in a designated Takeda-sponsored ixazomib clinical study, and in the investigator’s opinion and approved by the Takeda medical monitor, may benefit from continued therapy with 1 or more of the study drugs from a parent protocol (eg. response to therapy or stable disease without evidence of disease progression).; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001681-28-SE
• Lead Sponsor: Takeda Development Center Americas, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Patients previously treated with ixazomib background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Patients will be eligible to enter the rollover study when:
a) The parent study is closed or planned to be closed; and
b) The patient 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 (ie, Studies C16003, C16005, C16006, C16007,
C16008, C16010 Global, C16011, C16013, C16014 Global and Korean Continuation, C16017, C16020, C16029, and C16047); and
c) In the opinion of the investigator and approved by the Takeda medical monitor, the patient may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (eg, response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (eg, commercial supply).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
1. The patient 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified