DZB-CS-202: phase 1b/2 HER2-negative gastric adenocarcinoma study
Research type
Research Study
Full title
A Phase 1b/2 study of derazantinib as second-line monotherapy and combination therapy with paclitaxel, ramucirumab or atezolizumab in patients with HER2- negative gastric adenocarcinoma harboring FGFR genetic aberrations (FIDES-03)
IRAS ID
229134
Contact name
John Allen Bridgewater
Contact email
Sponsor organisation
Basilea Pharmaceutica International Ltd
Eudract number
2019-004505-27
Clinicaltrials.gov Identifier
146726, IND
Duration of Study in the UK
4 years, 4 months, 8 days
Research summary
This is a study that is built to combine three studies in one, all participants, the Medical staff and Sponsor/CRO will know which medication the participant will receive. This is a study for participants with stomach cancer called HER2neg gastric adenocarcinoma.
Sub-study one is to obtain data to assess the efficacy (how well a drug works) of study drug derazantinib as monotherapy (single treatment).
Sub-study 2 is a dose finding study, so different doses will be given to participants to find the safest dose of study drug derazantinib when given in combination with approved standard treatment: paclitaxel and ramucirumab.
Sub-study 3 will obtain data to compare the efficacy of the study drug as monotherapy, in combination with paclitaxel-ramucirumab and in combination with atezolizumab in comparison to the control arm of approved standard treatment: paclitaxel-ramucirumab
The study will also investigate the safety and tolerability and PK (pharmacokinetic; how the study drug is absorbed, distributed and removed by the body) of the study drug as monotherapy and with standard treatment.
There will be an option translational clinical study in sub-study 3 to explore molecular and gene expression profiles, selection and/or pharmacodynamic biomarkers.
The study consists of the following:
- Screening Period (up to 4 weeks)
- Treatment Period
- Safety Follow-up Period
Derazantinib will be taken as an oral tablet every day. Paclitaxel is given as an intravenous infusion on day 1, 8 and 15 of every cycle. Ramucirumab is given as an intravenous infusion on day 1 and 15 of every cycle. Atezolizumab is given as an intravenous infusion on day 1 of every cycle.This study is open label so the study participant and study doctor will know which study treatment the participant will receive.
254 participants will be enrolled globally.
The study sponsor is called Basilea Pharmaceutica.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0207
Date of REC Opinion
9 Jul 2020
REC opinion
Further Information Favourable Opinion