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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cobimetinib

    Drug

    Given PO

  • Olaparib

    Drug

    Given PO

  • Onvansertib

    Drug

    Given PO

  • Azenosertib

    Drug

    Given PO

  • Saruparib

    Drug

    Given PO

  • Tremelimumab

    Biological/Vaccine

    Given IV

Treatment groups

90 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm OlaparibExperimental treatment 1 intervention
Group B: Arm CobimetinibExperimental treatment 1 intervention
Group C: Arm OnvansertibExperimental treatment 1 intervention
Group D: Arm AzenosertibExperimental treatment 1 intervention
Group E: Arm AZD5305Experimental treatment 1 intervention
Group F: Arm TremelimumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of all pharmacodynamic feasibility-evaluable participants within a study arm that have a measurable change in post-treatment tumor biology from baseline

Will be estimated with a 95% confidence interval (CI).

Time frame
Changes in tumor biology from baseline (i.e., Day 0) and on-treatment biopsy (i.e., 10 days from start of study intervention)

Secondary outcomes

1

Incidence of >= grade 3 toxicities for each assigned window treatment (as described in sub-protocol)

Assessed per Common Terminology Criteria for Adverse Events version 5.0. The 95% CI will be reported with the point estimate of toxicity rate. All grade 3+ acute toxicities will also be summarized with its grade.

Time frame
Up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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