SBRTPhase 2NCT04698915
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
A Phase 2 study testing Drug GC4711 in people with SBRT and Borderline Resectable Pancreatic Cancer, run by Galera Therapeutics, Inc. at 35 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer
- What is being tested?
- Drug GC4711
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 7 May 2021to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
- Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
- Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
- Remain non-metastatic as confirmed by a CT scan at screening.
- Female or male subjects ≥ 18 years of age
- ECOG performance status of 0-2
- Adequate end-organ function
Who cannot join
- Subjects with documented metastatic disease
- First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
- Prior abdominal RT with substantial overlap in radiation fields
- Subjects not recovered/controlled from treatment-related toxicities
- Uncontrolled malignancy other than PC
- Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
- Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States21 sites
University Hospitals of Cleveland
Cleveland, Ohio, 44106
UT Southwestern Medical
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48208
Duke University Medical Center
Durham, North Carolina, 27710
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Hackensack Meridian Health
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Northwell Health
Lake Success, New York, 11042
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33146
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Orlando Health Cancer Institute
Orlando, Florida, 32806
Radiation Oncology and Gamma Knife Center of Oregon
Portland, Oregon, 97210
Mayo Clinic Rochester
Rochester, Minnesota, 55902
University of Washington Medical Center (UWMC) - Radiation Oncology Center
Seattle, Washington, 98195
Cancer Care Northwest
Spokane Valley, Washington, 99216
Moffitt Cancer Center
Tampa, Florida, 33612
Pennsylvania State University
University Park, Pennsylvania, 16082
France6 sites
Institut Bergonié
Bordeaux
CHRU de Brest Hôpital Morvan
Brest, 29200
Centre Georges François Leclerc
Dijon, 21079
Institut régional du Cancer de Montpellier
Montpellier, 34090
Tenon Hospital
Paris, 75020
CHU de Bordeaux, Hôpital Haut-Lévêque
Pessac, 33600
United Kingdom5 sites
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2SZ
Addenbrookes Hospital
Cambridge
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Imperial College London, Saint Mary's Hospital
London, W2 1NY
GenesisCare
Oxford, Oxfordshire, OX4 6LB
Canada3 sites
Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre
Halifax, Nova Scotia, B3J 3R4
London Regional Cancer Center
London, Ontario, ON N6A 5W9
Jewish General Hospital
Montreal, Quebec
About this study
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
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
- Being tested
- Drug GC4711, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug GC4711Drug
15 Minute IV Infusion
PlaceboDrug
15 Minute IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A Active GC4711 | Experimental | Not described Receives: Drug: Drug GC4711 |
| Arm B Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start7 May 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Futility Analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SBRTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698915
- Sponsor's protocol ID
- GTI-4711-201
- Status last verified
- Apr 2024
- First submitted
- 5 Jan 2021
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoffe SE, Aguilera TA, Parikh PJ, Ghaly MM, Herman JM, Caster JM, Kim DW, Costello J, Malafa MP, Moser EC, Kennedy EP, Terry K, Kurman M. Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design. Future Oncol. 2024 Mar;20(8):437-446. doi: 10.2217/fon-2022-1219. Epub 2024 Jan 24.
PubMed 38264869Taniguchi CM, Frakes JM, Aguilera TA, Palta M, Czito B, Bhutani MS, Colbert LE, Abi Jaoude J, Bernard V, Pant S, Tzeng CD, Kim DW, Malafa M, Costello J, Mathew G, Rebueno N, Koay EJ, Das P, Ludmir EB, Katz MHG, Wolff RA, Beddar S, Sawakuchi GO, Moningi S, Slack Tidwell RS, Yuan Y, Thall PF, Beardsley RA, Holmlund J, Herman JM, Hoffe SE. Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial. Lancet Oncol. 2023 Dec;24(12):1387-1398. doi: 10.1016/S1470-2045(23)00478-3.
PubMed 38039992Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
PubMed 34145168
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04698915
- Acronym / sponsor ID
- GTI-4711-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility Analysis
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Active GC4711 | Experimental | Drug: Drug GC4711 |
| Arm B Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
- Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
- Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
- Remain non-metastatic as confirmed by a CT scan at screening.
- Female or male subjects ≥ 18 years of age
Key exclusion criteria (7 listed)
- Subjects with documented metastatic disease
- First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
- Prior abdominal RT with substantial overlap in radiation fields
- Subjects not recovered/controlled from treatment-related toxicities
- Uncontrolled malignancy other than PC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug GC471115 Minute IV Infusion | Drug | Arm A Active GC4711 |
| Placebo15 Minute IV Infusion | Drug | Arm B Placebo |
Primary outcome
Overall Survival
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38264869Hoffe SE, Aguilera TA, Parikh PJ, Ghaly MM, Herman JM, Caster JM, Kim DW, Costello J, Malafa MP, Moser EC, Kennedy EP, Terry K, Kurman M. Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design. Future Oncol. 2024 Mar;20(8):437-446. doi: 10.2217/fon-2022-1219. Epub 2024 Jan 24.
- Derived from this study: PubMed 38039992Taniguchi CM, Frakes JM, Aguilera TA, Palta M, Czito B, Bhutani MS, Colbert LE, Abi Jaoude J, Bernard V, Pant S, Tzeng CD, Kim DW, Malafa M, Costello J, Mathew G, Rebueno N, Koay EJ, Das P, Ludmir EB, Katz MHG, Wolff RA, Beddar S, Sawakuchi GO, Moningi S, Slack Tidwell RS, Yuan Y, Thall PF, Beardsley RA, Holmlund J, Herman JM, Hoffe SE. Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial. Lancet Oncol. 2023 Dec;24(12):1387-1398. doi: 10.1016/S1470-2045(23)00478-3.
- Derived from this study: PubMed 34145168Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug GC4711 in people with SBRT and Borderline Resectable Pancreatic Cancer, run by Galera Therapeutics, Inc. at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698915, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.