Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Panbela Therapeutics, Inc.
Study ID
NCT05254171
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SBP-101 — DRUG
    small molecule polyamine metabolic inhibitor for subcutaneous injection
  • Nab-paclitaxel — DRUG
    paclitaxel protein-bound particles for injectable suspension
  • Gemcitabine — DRUG
    gemcitabine for injection
  • Placebo — OTHER
    Normal Saline

Study Details

The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.

Key Dates

Start date
Aug 8, 2022
Status verified
Jul 2024
Primary completion
Aug 29, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    SBP-101 + Nab-paclitaxel and Gemcitabine
  • Placebo Comparator: Control Arm
    Placebo + Nab-Paclitaxel and Gemcitabine

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of first dose up to 100 weeks or until death ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Genesis Cancer and Blood Institute (SCRI)Hot SpringsArkansas71913-
Providence Medical FoundationFullertonCalifornia92835
Jagruti Khandhadia
[email protected]
714-446-5900
Yale Cancer CenterNew HavenConnecticut06519
Jill Lacy, MD
[email protected]
203-737-1600
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Henry Ford Health SystemDetroitMichigan48202-2643
Philip Philip, MD
[email protected]
313-576-8728
CentraCare HealthSaint CloudMinnesota56303-
Columbia University Medical CenterNew YorkNew York10032
Navigator Office Nurse
[email protected]
212-342-5162
University of RochesterRochesterNew York14642
Chris LeFeber
[email protected]
585-275-0407
Mark H Zangmeister Center - SCRI - PPDSColumbusOhio43219-
Tennessee Oncology NASH - SCRI - PPDSNashvilleTennessee37203-
HOPE Cancer Center of East TexasTylerTexas75701
Grace Loredo
[email protected]
903-592-6152
Medical Oncology Associates - SpokaneSpokaneWashington99208
Monika Chaudhry, PhD
[email protected]
509-462-2273
MultiCare Regional Cancer Center - TacomaTacomaWashington98405
Samantha Blake
[email protected]
253-572-7320
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
414-805-8900
Mandana Kamgar, Study Principle Investigator

Find similar trials in Hot Springs, AR

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Genesis Cancer and Blood Institute (SCRI)· Hot Springs, ARProvidence Medical Foundation· Fullerton, CAYale Cancer Center· New Haven, CTMedStar Georgetown University Hospital· Washington D.C., DCHenry Ford Health System· Detroit, MICentraCare Health· Saint Cloud, MN

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