Clinical trialPhase 2Terminated
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
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
- Outcome
- Stopped earlyFutility Analysis (Efficacy or futility)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 7 May 2021
- Expected end
- 30 November 2023
- Enrollment
- 177 participants
- Sites
- 35
- Primary outcomes
- Overall Survival
- Sponsor
- Industry
- Results posted
- 2024-05-21
- Last update
- 21 May 2024
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Brief summary public domain (ClinicalTrials.gov)
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
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
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)]. Count Of Participants, Participants. Arm A Active GC4711 (n=84): 24; Arm B Placebo (n=84): 20.
Papers 3
- Builds on itStereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2… DOI 10.2217/fon-2022-1219↗
- Builds on itStereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, r… DOI 10.1016/s1470-2045(23)00478-3↗
- Builds on itNitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. DOI 10.1097/j.pain.0000000000002347↗