Description:
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
Title
- Brief Title: Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
- Official Title: GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
GTI-4711-201
- NCT ID:
NCT04698915
Conditions
- SBRT
- Borderline Resectable Pancreatic Cancer
- Unresectable Pancreatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
Drug GC4711 | | Arm A Active GC4711 |
Placebo | | Arm B Placebo |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A Active GC4711 | Experimental | | |
Arm B Placebo | Placebo Comparator | | |
Eligibility Criteria
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
(m)FOLFIRINOX and SBRT
3. Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy
4. Female or male subjects ≥ 18 years of age
5. ECOG performance status of 0-2
6. Adequate end-organ function
Exclusion Criteria:
1. Subjects with documented metastatic disease
2. First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total
period of longer than 4 months prior to start of SBRT
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Median Overall Survival after SBRT completion |
Time Frame: | From randomization up to 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Median Progression Free Survival after SBRT Completion per RESIST 1.1 |
Time Frame: | From randomization up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Galera Therapeutics, Inc. |
Last Updated
July 6, 2021