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NCT05494866: IntenSify
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1 trial testing Cobicistat Oral Tablet in CYP3A Inhibitor in 6 participants. Terminated before completion.
15 March 2024
Quick facts
| Lead sponsor | German Cancer Research Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 7 December 2022 |
| Primary completion | 15 March 2024 |
| Estimated completion | 15 March 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Cobicistat Oral Tablet — full drug profile →
- Gemcitabin — full drug profile →
- Nab paclitaxel
Conditions studied
- CYP3A Inhibitor — all drugs for CYP3A Inhibitor →
- Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma — all drugs for Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma →
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
- Pancreatic Adenocarcinoma — all drugs for Pancreatic Adenocarcinoma →
Sponsor
German Cancer Research Center — full company profile →
Who can join
18 and older, any sex, with CYP3A Inhibitor or Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To explore the possibility to overcome CYP3A-mediated resistance to anticancer drugs in pancreatic cancer, we will investigate the pharmacokinetics, safety, tolerability, and efficacy of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine and the CYP3A inhibitor cobicistat in a phase I proof-of-concept trial to determine the safety profile, the recommended dose of nab-paclitaxel in combination with gemcitabine and cobicistat, and to determine whether there is an early efficacy signal warranting a larger scale trial. The present trial is an open-label trial consisting of a dose-escalation part and an expansion part. The dose escalation part is designed to determine the safety, tolerability, and pharmacokinetics of nab-paclitaxel in combination with gemcitabine and cobicistat and will guide the dosing in the expansion part of the trial. The trial enrolls patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma and adequate performance score (ECOG PS 0-2) who would usually receive gemcitabine and nab-paclitaxel according to standard of care. Primary endpoint for the phase I trial is the safety of the combination. Overall survival (OS), disease control rate (DCR), overall response rate (ORR), duration of response (DoR) and progression free survival (PFS) are secondary efficacy endpoints. Further secondary endpoints are tolerability, pharmacokinetics, pharmacodynamics, and pharmacogenomics.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Protocol of the IntenSify-Trial: An open-label phase I trial of the CYP3A inhibitor cobicistat and the cytostatics gemcitabine and nab-paclitaxel in patients with advanced stage or metastatic pancreatic ductal adenocarcinoma to evaluate the combination's pharmacokinetics, safety,
Hohmann N, Sprick MR, Pohl M, Ahmed A, et al · · 2023 · cited 5× · PMID 37920921 · DOI 10.1111/cts.13661
Verify or expand the search:
- PubMed search for NCT05494866
- 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 NCT05494866 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 German Cancer Research Center
- Last refreshed: 25 March 2025
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