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NCT00031694
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
Phase 2 trial testing paclitaxel in Acinar Cell Adenocarcinoma of the Pancreas in 19 participants. Completed in 1 April 2010.
1 April 2010
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 1 March 2002 |
| Primary completion | 1 April 2010 |
| Estimated completion | 1 April 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- paclitaxel — full drug profile →
- bryostatin 1 — full drug profile →
Conditions studied
- Acinar Cell Adenocarcinoma of the Pancreas — all drugs for Acinar Cell Adenocarcinoma of the Pancreas →
- Duct Cell Adenocarcinoma of the Pancreas — all drugs for Duct Cell Adenocarcinoma of the Pancreas →
- Recurrent Pancreatic Cancer — all drugs for Recurrent Pancreatic Cancer →
- Stage III Pancreatic Cancer — all drugs for Stage III Pancreatic Cancer →
Sponsor
National Cancer Institute (NCI)
Who can join
19 and older, any sex, with Acinar Cell Adenocarcinoma of the Pancreas or Duct Cell Adenocarcinoma of the Pancreas. 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.
-
Response Rate of at Least 30%
Time frame: Up to 8 years
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Sponsor's own description
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Emerging Role of Cyclin-Dependent Kinases (CDKs) in Pancreatic Ductal Adenocarcinoma.
García-Reyes B, Kretz AL, Ruff JP, von Karstedt S, et al · · 2018 · cited 54× · PMID 30340359 · DOI 10.3390/ijms19103219 -
Targeting RAS phosphorylation in cancer therapy: Mechanisms and modulators.
Qiu Y, Wang Y, Chai Z, Ni D, et al · · 2021 · cited 35× · PMID 34900528 · DOI 10.1016/j.apsb.2021.02.014 -
Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma.
Lam AP, Sparano JA, Vinciguerra V, Ocean AJ, et al · · 2010 · cited 32× · PMID 19738452 · DOI 10.1097/coc.0b013e3181a31920 -
Biology, pathology, and therapeutic targeting of RAS.
Rhett JM, Khan I, O'Bryan JP. · · 2020 · cited 18× · PMID 32723567 · DOI 10.1016/bs.acr.2020.05.002
Verify or expand the search:
- PubMed search for NCT00031694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00031694 (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 National Cancer Institute (NCI)
- Last refreshed: 18 May 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/NCT00031694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing