Study of Carfilzomib, Carboplatin, and Etoposide in lung cancer
Research type
Research Study
Full title
Phase 1b/2, Multicenter, Open-label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects with Previously Untreated Extensive-stage Small-cell Lung Cancer
IRAS ID
140265
Contact name
Yvonne Summers
Contact email
Sponsor organisation
Onyx Therapeutics, Inc.
Eudract number
2013-002597-44
Research summary
There are 2 portions in this study. In the first portion (Phase 1b), several dose levels of carfilzomib were explored to determine the best dose to use in combination with carboplatin and etoposide. UK will only be participating in the Phase 2 portion of the study. The two main purposes of this study are to determine what the maximum dose of Carfilzomib can be in patients with extensive-stage small cell lung cancer and second is to see if the combination of Carfilzomib with carboplatin and etoposide can extend the length of time that the patient’s ES-SCLC remains stable. This will be done by comparing the study treatment to carboplatin and etoposide alone, in patients with SCLC who have not received initial cancer treatment. Eligible participants will be treated with Carfilzomib in combination with the standard treatment during the first phase then then the second phase treated with Carfilzomib and standard treatment or just the standard treatment. Half the participants will receive the study medication with standard treatment whilst the other half will receive standard treatment only. Both the participants and the study team will know which combination of medication the participants will be receiving. The participants will receive treatment in 3 week cycles. If the disease remains the same or gets better, participants can remain in the study and receive treatment for up to 6 cycles. After the last visit the participant will be followed for collection of information every 6 weeks for a minimum of 1 year until their disease progresses.
Participants who discontinue from treatment, will be followed for collection of information every 12 weeks for a minimum of 1 year, unless the participant wishes to withdraw consent from the study. This study will be conducted in approximately 50 centres around the world with approximately 110 patients enrolled.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0820
Date of REC Opinion
10 Feb 2014
REC opinion
Further Information Favourable Opinion