TerminatedPhase 1/2

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

Stopped: Terminated prematurely for administrative reasons not related to patient safety.

United States, Argentina, Australia47 participantsStarted 2020-10-06

Plain-language 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) i.e. 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach.
✓. Negative HER2 status obtained from the most recent available tissue sample.
✓. Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV adenocarcinoma of the gastro-esophageal junction or stomach, and prior anti-tumor treatment as specified for each Substudy. Patients were required to be staged as inoperable at the time of screening in order to avoid interference of any potentially planned surgery with RECIST requirements during the study:
✓. Eligible FGFRfus/amp/mt positive test result. For Substudy 1 Cohort 1.1, FGFR2fus/amp; for Cohort 1.2, FGFR1-3mt; for Cohort 1.3, FGFRfus/amp/mt. For Substudy 2, FGFRfus/amp/mt.
✓. Measurable disease as defined by the Investigator using RECIST 1.1 criteria
✓. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
✓. Adequate organ functions as indicated by Screening visit laboratory values.

What they're measuring

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

Timeframe: From first dose and up to 18 months

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

Timeframe: From first dose and up to 4 months

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

Timeframe: From first dose and up to 18 months

Trial details

NCT IDNCT04604132

SponsorBasilea Pharmaceutica

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-21

Results submitted2023-11-21

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach.
✓. Negative HER2 status obtained from the most recent available tissue sample.
✓. Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV adenocarcinoma of the gastro-esophageal junction or stomach, and prior anti-tumor treatment as specified for each Substudy. Patients were required to be staged as inoperable at the time of screening in order to avoid interference of any potentially planned surgery with RECIST requirements during the study:
✓. Eligible FGFRfus/amp/mt positive test result. For Substudy 1 Cohort 1.1, FGFR2fus/amp; for Cohort 1.2, FGFR1-3mt; for Cohort 1.3, FGFRfus/amp/mt. For Substudy 2, FGFRfus/amp/mt.
✓. Measurable disease as defined by the Investigator using RECIST 1.1 criteria
✓. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
✓. Adequate organ functions as indicated by Screening visit laboratory values.

What they're measuring

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

Timeframe: From first dose and up to 18 months

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

Timeframe: From first dose and up to 4 months

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

Timeframe: From first dose and up to 18 months