Health Trials

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

ConditionsLocally Advanced Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Pancreatic Ductal AdenocarcinomaBorderline Resectable Pancreatic Ductal AdenocarcinomaResectable Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

This early phase I trial aims to determine how cobimetinib, olaparib, onvansertib, azenosertib, AZD5305 or tremelimumab works in patients with pancreatic cancer. Validation of cobimetinib, olaparib, onvansertib azenosertib, AZD5305 and tremelimumab molecular targets will be explored by comparing pre-treatment biopsies with post-treatment specimens. This knowledge will help design future biomarker driven trials to determine whether giving cobimetinib, or olaparib, or onvansertib or azenosertib, or AZD5305, or tremelimumab will work better than standard treatments in patients with pancreatic cancer.

Eligibility criteria

Qualifiers

Ability to understand and the willingness to sign a written informed consent document

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Clinically-confirmed diagnosis of resectable, borderline resectable, locally-advanced or metastatic adenocarcinoma of the pancreas.

Disqualifiers

Tumor not accessible for core biopsy

Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards

Recent major surgery within 4 weeks prior to starting study treatment. Minor surgery within 2 weeks of starting study treatment. Patients must be recovered from effects of surgery

Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil)

Trial design

Treatments tested in this trial

  • Cobimetinib
  • Olaparib
  • Onvansertib
  • Azenosertib
  • Saruparib
  • Tremelimumab

Treatment groups

90 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

American Association for Cancer Research

Collaborator

Oregon Health and Science University

Collaborator

Genentech, Inc.

Collaborator

Cardiff Oncology

Collaborator

Source ClinicalTrials.gov