Borderline Resectable Pancreatic Cancer, SBRT, Unresectable Pancreatic Cancer
Conditions
Brief summary
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
Interventions
DRUGDrug GC4711
15 Minute IV Infusion
DRUGPlacebo
15 Minute IV Infusion
Sponsors
Galera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained. 2. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT 3. Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT 4. Remain non-metastatic as confirmed by a CT scan at screening. 5. Female or male subjects ≥ 18 years of age 6. ECOG performance status of 0-2 7. Adequate end-organ function
Exclusion criteria
1. Subjects with documented metastatic disease 2. First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen 3. Prior abdominal RT with substantial overlap in radiation fields 4. Subjects not recovered/controlled from treatment-related toxicities 5. Uncontrolled malignancy other than PC 6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing 7. Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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) | 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. |
Countries
Canada, France, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A Active GC4711 Drug GC4711: 15 Minute IV Infusion | 84 |
| Arm B Placebo Placebo: 15 Minute IV Infusion | 84 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 23 | 20 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Study Terminated by Sponsor | 55 | 60 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Arm A Active GC4711 | Arm B Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 46 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 38 Participants | 74 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 16 Participants |
| Race (NIH/OMB) White | 70 Participants | 67 Participants | 137 Participants |
| Sex: Female, Male Female | 44 Participants | 42 Participants | 86 Participants |
| Sex: Female, Male Male | 40 Participants | 42 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 84 | 20 / 84 |
| other Total, other adverse events | 76 / 84 | 71 / 84 |
| serious Total, serious adverse events | 17 / 84 | 14 / 84 |
Outcome results
Primary
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)
Population: Modified Intent to Treat Population that includes all randomized subjects that received at least one dose of GC4711/Placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A Active GC4711 | Overall Survival | 24 Participants |
| Arm B Placebo | Overall Survival | 20 Participants |