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.
- Conditions
- The patient population will consist of patients who have previously received and tolerated ixazomib in a Millennium-sponsored clinical study, and in the investigator’s opinion and confirmed by the Millennium medical monitor, may benefit from continued ixazomib therapy. In Belgium the indication of the parent study is relapsed and/or refractory Follicular LymphomaMedDRA version: 20.0Level: LLTClassification code 10029478Term: Nodular lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001681-28-BE
- Lead Sponsor
- Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Patients previously treated with ixazomib (excluding comparator or placebo patients not on current treatment with ixazomib) in a Millennium-sponsored 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 or on a drug combination with another medication, established while in his/her parent study; and
c.In the opinion of the investigator and confirmed by the Millennium medical monitor, the patient may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).
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
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
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective: To provide continued access of ixazomib and to evaluate the long-term safety profile of ixazomib.;Secondary Objective: There are no secondary objectives.;Primary end point(s): The primary endpoint is safety, as assessed by the incidence of the following AEs:<br>•All SAEs.<br>•All =Grade 3 AEs.<br>•=Grade 2 peripheral neuropathy.<br>•New primary malignancies.<br>•Any AE resulting in dose modification or discontinuation of any study drug.<br>•Any other AE that in the opinion of the investigator is a clinically significant event.<br>;Timepoint(s) of evaluation of this end point: Up to 5 years of treatment with ixazomib in this study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable. ;Timepoint(s) of evaluation of this end point: Not applicable.