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Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Phase 2 trial testing Drug GC4711 in SBRT in 177 participants. Terminated before completion.
| Lead sponsor | Galera Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 177 |
| Start date | 7 May 2021 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 November 2023 |
| Sites | 35 locations across France, Canada, United States, United Kingdom |
Galera Therapeutics, Inc. — full company profile →
18 and older, any sex, with SBRT or Borderline Resectable Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
| Group | Value | 95% CI |
|---|---|---|
| Arm A Active GC4711 | 24 | |
| Arm B Placebo | 20 |
Time frame: All AEs/SAES were monitored/assessed from time of randomization until up to 30 days post the last dose of GC4711/Placebo (2 months). Since the primary endpoint of the trial was overall survival, deaths were assessed for a longer duration than AEs/SAEs. Due to the study being terminated early, all subject death information was collected for a minimum of 30 days post the last dose of GC4711/Placebo (2months). Reporting threshold: 5.0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|---|
| Sepsis | Infections and infestations | — | — |
| Pyrexia | General disorders | — | — |
| Blood Bilirubin Increased | Investigations | — | — |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Syncope | Nervous system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Duodenal Stenosis | Gastrointestinal disorders | — | — |
| Fistula of Small Intestine | Gastrointestinal disorders | — | — |
| Gastritis | Gastrointestinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Mesenteric Vein Thrombosis | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | — | — |
| Generalised Oedema | General disorders | — | — |
| Systemic Inflammatory Response Syndrome | General disorders | — | — |
| Bile Duct Obstruction | Hepatobiliary disorders | — | — |
| Bile Duct Stenosis | Hepatobiliary disorders | — | — |
| Cholangitis | Hepatobiliary disorders | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Cholecystitis Infective | Infections and infestations | — | — |
| Reaction | System | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Hypertension | Vascular disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Abdominal Distension | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Platelet Count Decreased | Investigations | — | — |
| Abdominal Pain Upper | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood Bilirubin Increased | Investigations | — | — |
| White Blood Cell Count Decreased | Investigations | — | — |
| Insomnia | Psychiatric disorders | — | — |
Most-reported serious reactions: Sepsis, Pyrexia, Blood Bilirubin Increased, Pancreatic Carcinoma Metastatic, Syncope, Anaemia, Febrile Neutropenia, Cardiac failure.
Data from ClinicalTrials.gov NCT04698915 adverse events section.
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
8 peer-reviewed publications reference this trial (live from Europe PMC):
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