Clinical trial

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

Name

C16027

Description

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

Trial arms

Trial start

2016-12-16

Estimated PCD

2023-12-31

Trial end

2023-12-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Ixazomib

Ixazomib Capsules

Arms:

Ixazomib

Other names:

MLN9708, Ninlaro

Size

Primary endpoint

Number of Participants With Serious Adverse Events (SAEs)

Up to 5 years

Number of Participants With ≥ Grade 3 AEs

Up to 5 years

Number of Participants With ≥ Grade 2 Peripheral Neuropathy

Up to 5 years

Number of Participants With New Primary Malignancies

Up to 5 years

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

Up to 5 years

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

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.

Protocol

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Updated at

2023-01-31

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication