Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Galera Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Borderline Resectable Pancreatic Cancer; Unresectable Pancreatic Cancer; SBRT

Treatments: Drug: Drug GC4711; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04698915

GTI-4711-201

Details and patient eligibility

About

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

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

177 participants in 2 patient groups, including a placebo group

Arm A Active GC4711

Experimental group

Treatment:

Drug: Drug GC4711

Arm B Placebo

Placebo Comparator group

Treatment:

Drug: Placebo