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

Phase 2

Terminated

• Conditions: SBRT; Borderline Resectable Pancreatic Cancer; Unresectable Pancreatic Cancer
• Interventions: Drug: Drug GC4711; Drug: Placebo

• Registration Number: NCT04698915
• Lead Sponsor: Galera Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-05-07
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Results First Submitted: 2024-03-01
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A Active GC4711	Drug GC4711	-
Arm B Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (35)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Orlando Health Cancer Institute; 🇺🇸 Orlando, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

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