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A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma

IntenSify: 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 and Efficacy

NCT05494866•German Cancer Research Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years
•2. Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas.
•7. Present treatment with phenprocoumon, warfarin or another coumadine-based anticoagulant.
•8. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
•9. Major surgery, other than for diagnostic purposes ((done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
•10. History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
•11. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise patient's safety or study data integrity.
•12. Participation in any other interventional clinical protocol or investigational trial.
•13. Unwillingness or inability to comply with study procedures.
•14. Therapy with a narrow therapeutic index drug that is substrate of CYP3A, CYP2D6, or CYP2C9 whose dose cannot be appropriately adjusted.
+2 more criteria

Exclusion Criteria

•4. Eligible for therapy with gemcitabine / nab-paclitaxel according to standard of care / local therapeutic standard (in any palliative therapy line)
•5. Performance score ECOG 0-2
•6. Adequate organ function defined as:
•1. Adequate hematologic function (WBC ≥3000/µL, absolute neutrophil count ≥1500/µL, platelets ≥100.000/µL, hemoglobin ≥8 g/dL)
•2. Adequate renal function (estimated glomerular filtration rate ≥30 mL/min)
•3. Adequate liver function (serum bilirubin ≤1.5 x ULN, AST/ALT ≤2.5 x ULN, or 5 x ULN if hepatic metastases are present)
•4. Prothrombintime (PT) \<1.1 ULN, partial thromboplastin time \<1.1 ULN, INR \<1.1 ULN.
•7. Use of reliable contraception with a Pearl Index \<1% (i.e. two independent effective contraceptive methods) during the trial and for two weeks after the last administration of trial medication in men or women of child bearing potential (WOCBP).
•8. Measurable disease according to RECIST 1.1 criteria.
•9. Patient willing to undergo tumor biopsy. This requires a tumor lesion accessible for a biopsy. In patients without an accessible tumor lesion the patient may be enrolled and tumor biopsy waived after discussion with the sponsor's medical representative.
+7 more criteria

Locations (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Key Dates

Start Date

December 7, 2022

Primary Completion Date

March 15, 2024

Completion Date

March 15, 2024

Last Updated

March 25, 2025

Enrollment

ACTUAL participants

Conditions

CYP3A InhibitorAdvanced Stage or Metastatic Pancreatic Ductal AdenocarcinomaPancreatic CancerPancreatic AdenocarcinomaPancreatic Neoplasm

Interventions

Cobicistat Oral Tablet

DRUG

Gemcitabin

DRUG

Nab paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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