Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604132
Status:
TERMINATED
Last Update Posted:
2024-04-04
First Post:
2020-10-21
Brief Title:
Derazantinib Alone or in Combination With Paclitaxel Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Phase 1b2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated prematurely for administrative reasons not related to patient safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIDES-03
Brief Summary:
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma GAC ie with human epidermal growth factor receptor 2 HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring fibroblast growth factor receptor 2 FGFR2 genetic aberrations GA
Detailed Description:
The study comprised two open-label substudies in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 gene translocations FGFR2 gene amplifications or FGFR1-3 mutations
In Substudy 1 GAC patients with specified FGFR GAs after either first- or second-line treatment and no approved treatment alternative were treated with derazantinib 300 mg once daily or 200 mg twice daily with the aim of evaluating the safety tolerability and efficacy of derazantinib monotherapy in this patient population
In Substudy 2 GAC patients with specified FGFR GAs after standard first-line treatment were treated with a derazantinib-paclitaxel-ramucirumab combination with the aim of evaluating the safety tolerability and efficacy of the combination therapy and determining the recommended phase 2 dose RP2D
The study originally planned to include three substudies but was prematurely terminated for administrative reasons before the third substudy including combination therapy with derazantinib plus atezolizumab was initiated
In Substudy 1 GAC patients with specified FGFR GAs after either first- or second-line treatment and no approved treatment alternative were treated with derazantinib 300 mg once daily or 200 mg twice daily with the aim of evaluating the safety tolerability and efficacy of derazantinib monotherapy in this patient population
In Substudy 2 GAC patients with specified FGFR GAs after standard first-line treatment were treated with a derazantinib-paclitaxel-ramucirumab combination with the aim of evaluating the safety tolerability and efficacy of the combination therapy and determining the recommended phase 2 dose RP2D
The study originally planned to include three substudies but was prematurely terminated for administrative reasons before the third substudy including combination therapy with derazantinib plus atezolizumab was initiated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None