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.

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001681-28-ES

Enrollment

Registered

2016-09-09

Start date

2016-10-27

Completion date

Unknown

Last updated

2016-10-31

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

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. MedDRA version: 19.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864

Interventions

Trade Name: NINLARO Product Name: NINLARO 2.3 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ixazomib CAS Number: 1072833-77-2 Current Sponsor code: NINLARO Other descriptive name: IXAZOMI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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: •All SAEs. •All =Grade 3 AEs. •=Grade 2 peripheral neuropathy. •New primary malignancies. •Any AE resulting in dose modification or discontinuation of any study drug. •Any other AE that in the opinion of the investigator is a clinically significant event.;Timepoint(s) of evaluation of this end point: Up to 5 years of treatment with ixazomib in this study.	—

Measure

Time frame

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: •All SAEs. •All =Grade 3 AEs. •=Grade 2 peripheral neuropathy. •New primary malignancies. •Any AE resulting in dose modification or discontinuation of any study drug. •Any other AE that in the opinion of the investigator is a clinically significant event.;Timepoint(s) of evaluation of this end point: Up to 5 years of treatment with ixazomib in this study.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Belgium, Canada, Korea, Republic of, Singapore, Spain, United States

Contacts

Public ContactDrug Information Call Center

Millennium Pharmaceuticals, Inc.

medical@mlnm.com+15107402412

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026