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Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

NCT03412799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-25

No results posted yet for this study

Summary

This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.

Conditions

  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Stage IV
  • Stage IV Pancreatic Cancer

Interventions

DRUG

SBP-101

Administered as subcutaneous (SC) injection, escalating dose cohorts

DRUG

nab-paclitaxel

Administered as intravenous (IV) infusion

DRUG

Gemcitabine Injection

Administered as intravenous (IV) infusion

Sponsors & Collaborators

  • Panbela Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Suzanne Gagnon, MD · Panbela Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412799 on ClinicalTrials.gov