C16017 Ph2 Study of Oral MLN9708 in Patients with Follicular Lymphoma
Research type
Research Study
Full title
An Open-label, Multicenter, Phase 2 Study of Oral MLN9708 in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma
IRAS ID
135241
Contact name
John Radford
Contact email
Sponsor organisation
PPD Global Limited
Eudract number
2013-002302-32
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
Non-Hodgkin lymphoma (NHL) is a mixed group of lymphoid malignancies, representing 3% of all cancer deaths. Follicular lymphoma (FL) is the most common indolent NHL and the second most common form of NHL overall, accounting for approximately 20% of all cases of NHL.
Significant advances have been made in the treatment of patients with NHL in the last decade, largely contributed to by the introduction of biological agents, notably rituximab, into the conventional chemotherapy regimens. However, the majority of patients with NHL are not cured and new therapeutic options are therefore needed. This need is particularly acute for patients who have received multiple lines of prior therapies and progressed with very limited treatment options available. However, FL remains an incurable disease and effective therapeutic options for FL patients who failed several lines of therapies are very limited. Novel and targeted therapies are therefore needed.
MLN9708 is the first oral drug which inhibits protein breakdown within a cell(proteosome inhibition). This drug is currently being investigated in humans, with particular emphasis on its safety, tolerability, drug movement and mechanism in the body. Data taken from clinical studies has shown that MLN9708 has the ability to target the tumour and also suppress it.
This study is an open-label, multicenter, phase 2 clinical study to evaluate the effectiveness and safety of oral MLN9708 in adult patients with FL that is relapsed and/or refractory to prior treatment. The study has a lead-in dose-finding phase in patients with any type of NHL. The phase 2 population will consist of adult men and women who have a confirmed laboratory diagnosis of FL, who have relapsed and/or refractory disease with documented progressive disease at the time of acceptance into the study after having received at least 1 prior therapy (excluding radiation), and who meet other outlined eligibility criteria.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0373
Date of REC Opinion
15 Nov 2013
REC opinion
Further Information Favourable Opinion