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

Phase 1

Terminated

• Conditions: CYP3A Inhibitor; Pancreatic Cancer; Pancreatic Adenocarcinoma; Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Neoplasm
• Interventions: Drug: Cobicistat Oral Tablet; Drug: Gemcitabin; Drug: Nab paclitaxel

• Registration Number: NCT05494866
• Lead Sponsor: German Cancer Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-12-07
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Cobicistat Oral Tablet	CYP3A Inhibitor Cobicistat and the cytostatics Gemcitabine and nab-Paclitaxel
Arm 1	Nab paclitaxel	CYP3A Inhibitor Cobicistat and the cytostatics Gemcitabine and nab-Paclitaxel
Arm 1	Gemcitabin	CYP3A Inhibitor Cobicistat and the cytostatics Gemcitabine and nab-Paclitaxel

Primary Outcome Measures

Name	Time	Method
occurrence of DLTs	Day 1 to day 28	occurrence of DLTs within treatment cycle 1

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, BW, Germany