A Phase 2 interventional study of Drug GC4711 and Placebo in SBRT, Borderline Resectable Pancreatic Cancer and Unresectable Pancreatic Cancer, sponsored by Galera Therapeutics, Inc.. Terminated at 35 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Galera Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 177 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Galera Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Drug GC4711
Drug: Placebo
15 Minute IV Infusion
15 Minute IV Infusion
Overall Survival
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.
Time frame: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)
| Milestone | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|
| Started | 84 | 84 |
| Completed | 0 | 0 |
| Not completed | 84 | 84 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Death | 23 | 20 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Study terminated by sponsor | 55 | 60 |
| Withdrew: Withdrawal by subject | 2 | 3 |
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.
| Participants | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|
| Overall Survival | 24 | 20 |
Collected over 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). Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A Active GC4711 | 24/84 (28.6%) | 17/84 (20.2%) | 76/84 (90.5%) |
| Arm B Placebo | 20/84 (23.8%) | 14/84 (16.7%) | 71/84 (84.5%) |
| Event | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|
| SepsisInfections and infestations | 4/84 | 2/84 |
| PyrexiaGeneral disorders | 2/84 | 0/84 |
| Blood Bilirubin IncreasedInvestigations | 2/84 | 2/84 |
| Pancreatic Carcinoma MetastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/84 | 2/84 |
| SyncopeNervous system disorders | 2/84 | 0/84 |
| AnaemiaBlood and lymphatic system disorders | 0/84 | 1/84 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/84 | 0/84 |
| Cardiac failureCardiac disorders | 0/84 | 1/84 |
| DiarrhoeaGastrointestinal disorders | 1/84 | 1/84 |
| Duodenal StenosisGastrointestinal disorders | 1/84 | 0/84 |
| Event | Arm A Active GC4711 | Arm B Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 44/84 | 32/84 |
| FatigueGeneral disorders | 38/84 | 26/84 |
| VomitingGastrointestinal disorders | 26/84 | 15/84 |
| HypotensionVascular disorders | 18/84 | 3/84 |
| Abdominal PainGastrointestinal disorders | 16/84 | 16/84 |
| DiarrhoeaGastrointestinal disorders | 15/84 | 13/84 |
| DizzinessNervous system disorders | 15/84 | 6/84 |
| Blood alkaline phosphatase increasedInvestigations | 10/84 | 4/84 |
| HypertensionVascular disorders | 8/84 | 10/84 |
| Back PainMusculoskeletal and connective tissue disorders | 6/84 | 9/84 |
Modified Intent to Treat Population that includes all randomized subjects that received at least one dose of GC4711/Placebo
| Age, Categorical(Participants) | Arm A Active GC4711 | Arm B Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 38 | 74 |
| >=65 years | 48 | 46 | 94 |
| Sex: Female, Male(Participants) | Arm A Active GC4711 | Arm B Placebo | Total |
|---|---|---|---|
| Female | 44 | 42 | 86 |
| Male | 40 | 42 | 82 |
| Race (NIH/OMB)(Participants) | Arm A Active GC4711 | Arm B Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 70 | 67 | 137 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 6 | 10 | 16 |
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Galera Therapeutics, Inc.