Last reviewed · How we verify
NCT00376948
Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
Phase 2 trial testing genistein in Pancreatic Cancer in 20 participants. Completed in 1 March 2010.
1 March 2010
Quick facts
| Lead sponsor | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 May 2005 |
| Primary completion | 1 March 2010 |
| Estimated completion | 1 March 2010 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- genistein — full drug profile →
- erlotinib hydrochloride — full drug profile →
- gemcitabine hydrochloride — full drug profile →
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
Sponsor
Barbara Ann Karmanos Cancer Institute
Who can join
Adults 21 to 120, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Patients Alive
Time frame: at 6 months -
Median Overall Survival Estimate
Time frame: up to 17 months
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine and erlotinib works in treating patients with locally advanced or metastatic pancreatic cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Perspectives for cancer prevention with natural compounds.
Amin AR, Kucuk O, Khuri FR, Shin DM. · · 2009 · cited 330× · PMID 19414669 · DOI 10.1200/jco.2008.20.6235 -
Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3 -
Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1 -
NF-kappaB and STAT3 signaling in glioma: targets for future therapies.
Atkinson GP, Nozell SE, Benveniste ET. · · 2010 · cited 110× · PMID 20367209 · DOI 10.1586/ern.10.21 -
Regulation of microRNAs by natural agents: new strategies in cancer therapies.
Phuah NH, Nagoor NH. · · 2014 · cited 90× · PMID 25254214 · DOI 10.1155/2014/804510 -
Harnessing the fruits of nature for the development of multi-targeted cancer therapeutics.
Sarkar FH, Li Y. · · 2009 · cited 88× · PMID 19660870 · DOI 10.1016/j.ctrv.2009.07.001 -
Natural compounds with proteasome inhibitory activity for cancer prevention and treatment.
Yang H, Landis-Piwowar KR, Chen D, Milacic V, et al · · 2008 · cited 70× · PMID 18537678 · DOI 10.2174/138920308784533998 -
Clinical development of novel proteasome inhibitors for cancer treatment.
Yang H, Zonder JA, Dou QP. · · 2009 · cited 67× · PMID 19505187 · DOI 10.1517/13543780903002074
Verify or expand the search:
- PubMed search for NCT00376948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of genistein
Trials testing the same drug.
- NCT04105023 — Genistein Stimulates Insulin Sensitivity Through Gut Microbiota · NA · completed
- NCT01126879 — Genistein in Treating Patients With Prostate Cancer · Phase 2 · terminated
Other recruiting trials for Pancreatic Cancer
Currently open trials in the same condition.
- NCT07126158 — Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma · Phase 2 · recruiting
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- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT07236177 — B-GLUCANCER2 : A Pilot Study Evaluating a New Method for Cancer Detection by Measuring the Activity of Different Glycosi · EARLY_PHASE1 · recruiting
Other Barbara Ann Karmanos Cancer Institute trials
Trials by the same sponsor.
- NCT07343297 — Ask Questions About Clinical Trials · NA · not yet recruiting
- NCT07118202 — TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma · NA · recruiting
- NCT07098299 — Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies · Phase 1 · recruiting
- NCT07130903 — Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Met · Phase 2 · recruiting
- NCT07095114 — A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients. · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00376948 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute
- Last refreshed: 25 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00376948.
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