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Checkpoint Inhibitor

Derazantinib for Stomach Cancer (FIDES-03 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Basilea Pharmaceutica

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose and up to 18 months

Awards & highlights

FIDES-03 Trial Summary

This trial is testing derazantinib, a drug that targets FGFR2, in patients with stomach or gastro-esophageal junction cancer that has a genetic aberration in FGFR2.

Eligible Conditions

Stomach Cancer

FIDES-03 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose and up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose and up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) in Substudy 1 (in Cohorts 1.1 and 1.2)

Progression-free Survival at 4 Months (PFS4) in Substudy 1 in Cohort 1.3

Recommended Phase 2 Dose (RP2D) in Substudy 2 (Derazantinib-paclitaxel-ramucirumab in Combination)

Secondary outcome measures

DCR in Substudy 2

DOR in Substudy 2 (Separate and Combined Cohorts)

Disease Control Rate (DCR) in Substudy 1: Cohort 1.1, 1.2 and 1.3 and Combined Cohorts

+7 more

FIDES-03 Trial Design

5Treatment groups

Experimental Treatment

Group I: Substudy 2: Derazantinib 300 mg once daily+Paclitaxel+ RamucirumabExperimental Treatment1 Intervention

Patients with FGFR fusions, amplifications or mutations were treated with 300 mg Derazantinib once daily combination with Paclitaxel and Ramucirumab

Group II: Substudy 2: Derazantinib 200 mg once daily +Paclitaxel+ RamucirumabExperimental Treatment1 Intervention

Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab

Group III: Substudy 1: Cohort 1.3 Derazantinib 200 mg twice dailyExperimental Treatment1 Intervention

Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib monotherapy twice daily

Group IV: Substudy 1: Cohort 1.2 Derazantinib 300 mg once dailyExperimental Treatment1 Intervention

Patients with FGFR1-3 mutations were treated with 300 mg Derazantinib monotherapy once daily

Group V: Substudy 1: Cohort 1.1 Derazantinib 300 mg once dailyExperimental Treatment1 Intervention

Patients with FGFR2 fusions or amplifications were treated with 300 mg Derazantinib monotherapy once daily

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Find a Location

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor

40 Previous Clinical Trials

9,028 Total Patients Enrolled

Manuel Häckl, MDStudy DirectorBasilea Pharmaceutica International Ltd, Allschwil

3 Previous Clinical Trials

243 Total Patients Enrolled

Inessa Polyakova, MDStudy DirectorBasilea Pharmaceutica International Ltd

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any existing research reports which detail the effects of a Derazantinib-paclitaxel-ramucirumab combination?

"In 1997, the City of Hope Comprehensive Cancer Center kickstarted research on derazantinib-paclitaxel-ramucirumab and since then, 1264 clinical trials have been completed. Currently, 1169 are actively recruiting patients with a large concentration in Orlando Florida."

Answered by AI

What is the typical application for Derazantinib-paclitaxel-ramucirumab?

"While derazantinib-paclitaxel-ramucirumab is most often prescribed for metastatic bladder cancer, its efficacy has been demonstrated in acquired immunodeficiency syndrome, advanced thymoma, and small cell lung carcinomas."

Answered by AI

Are there any unfilled vacancies in this clinical experiment?

"At this time, recruitment for the clinical trial has ceased. Initially published on October 6th 2020 and last edited August 8th 2022, it is no longer seeking participants. For those looking to join a medical trial related to adenocarcinoma or Derazantinib-paclitaxel-ramucirumab, there are currently 776 and 1169 studies recruiting patients respectively."

Answered by AI

What is the ultimate objective of this experiment?

"According to the trial sponsor, Basilea Pharmaceutica, the primary outcome that will be monitored over a 30 month period is Objective Response Rate (ORR) per RECIST 1.1 across two cohorts and three substudies. Additionally, secondary outcomes such as Duration of Response (DOR), Pharmacokinetic (PK) profile: The time to reach Cmax (Tmax) of derazantinib 200 mg twice daily monotherapy, and Progression-free Survival (PFS) are also being studied."

Answered by AI

How many individuals have participated in this research endeavor?

"Unfortunately, this clinical trial has concluded recruiting. It was initially posted on October 6th 2020 and most recently updated on August 8th 2022. If you are searching for similar trials there are currently 776 studies enrolling patients with adenocarcinoma and 1169 clinical trials accepting participants who may benefit from a Derazantinib-paclitaxel-ramucirumab combination therapy regimen."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

2020. "Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04604132.