Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

FIDES-03 : A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Stomach

Trial Overview Read MoreRead more

This Phase I/II trial is trying to understand how effective targeted therapy (derazantinib) is alone, or when combined with immunotherapy (atezolizumab) or chemotherapy (paclitaxel) and another targeted therapy (ramucirumab), compared to the standard of care treatment of paclitaxel and ramucirumab in people with HER2-negative gastric adenocarcinoma.
 

This trial is treating patients with gastric adenocarcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

Commercial Sponsor

Basilea Pharmaceutica

Summary

The study comprises three 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. The study enrolls patients with either metastatic or recurrent locally advanced HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction inoperable at the time of screening, and radiologically confirmed disease progression after one or at least one standard treatment regimen. The study has 4 cohorts: 3 experimental arms and 1 active comparator arm. Participants in Experimental Arm 1 will receive Derazantinib, administered orally 300mg daily as monotherapy. Participants in Experimental Arm 2 will receive Derazantinib-paclitaxel-ramucirumab. Derazantinib will be administered at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy2; Paclitaxel will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 on days 1, 8 and 15 of a 28-day cycle. Ramucirumab will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 every 2 weeks. Participants in Experimental Arm 3 will receive Derazantinib-atezolizumab. Derazantinib will be administered orally at a dose of 300mg daily. Atezolizumab will be administered intravenously at a dose of 1200mg every 3 weeks. Finally, participants in the Active Comparator Arm will receive the standard of Care treatment of paclitaxel-ramucirumab. Paclitaxel will be administered intravenously at a dose of 80 mg/m² on days 1, 8 and 15 of a 28-day cycle. Ramucirumab will be administered intravenously at a dose of 8mg/kg every 2 weeks.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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