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Anti-metabolites

Nab-Paclitaxel + Gemcitabine +/- SBP-101 for Pancreatic Cancer (ASPIRE Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Panbela Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Must not have
Any history of hydroxychloroquine use (Plaquenil® and other brand names).
Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 weeks
Awards & highlights

Summary

This trial is testing a new cancer treatment on patients with metastatic pancreatic cancer who haven't been treated before (or have only received neoadjuvant or adjuvant treatment).

Who is the study for?
This trial is for adults with newly diagnosed metastatic pancreatic ductal adenocarcinoma who haven't been treated for it yet. They should be able to perform daily activities with ease or have only slight limitations (ECOG 0-1), and their major organs must function well. Pregnant women, those with certain genetic mutations (BRCA positive), severe diseases, recent major surgery, or a history of specific drug use are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of SBP-101 added to standard chemotherapy drugs Nab-Paclitaxel and Gemcitabine in treating metastatic pancreatic cancer. Participants will either receive this combination or a placebo alongside the standard treatment in a randomized and double-blind setup.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. SBP-101 may also have its own unique side effects which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured on a scan.
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I am fully active or can carry out light work.
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I am not pregnant, can use birth control during the study, and if male, will also use contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken hydroxychloroquine (Plaquenil) before.
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I have a lung condition like interstitial lung disease or pulmonary fibrosis.
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I do not have an active HIV, hepatitis B, or C infection.
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I have had a blood clot or blockage in my veins during screening.
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I had major surgery less than 4 weeks ago and haven't fully recovered.
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I have tested positive for the BRCA gene mutation.
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I am willing to stop taking metformin for my diabetes during the study.
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I have a history of eye diseases affecting my vision.
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I have a specific type of pancreatic or islet-cell tumor.
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I am currently being treated for a serious infection.
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I haven't had a heart attack or severe heart issues in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Progression Free Survival (PFS)
Other outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Exploratory
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment3 Interventions
SBP-101 + Nab-paclitaxel and Gemcitabine
Group II: Control ArmPlacebo Group3 Interventions
Placebo + Nab-Paclitaxel and Gemcitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBP-101
2016
Completed Phase 1
~30
Paclitaxel
FDA approved
Gemcitabine
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapeutic agents like gemcitabine, nab-paclitaxel, and FOLFIRINOX. Gemcitabine is a nucleoside analog that inhibits DNA synthesis, leading to cell death. Nab-paclitaxel stabilizes microtubules, preventing cell division. FOLFIRINOX is a combination regimen that includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, each targeting different aspects of DNA replication and repair. These treatments are crucial for pancreatic cancer patients as they target rapidly dividing cancer cells, aiming to reduce tumor size and spread. SBP-101, a polyamine metabolic inhibitor, disrupts polyamine synthesis, which is essential for cell growth and differentiation, offering a novel approach by targeting metabolic pathways specific to cancer cells. Understanding these mechanisms helps in selecting appropriate therapies and developing new treatments to improve patient outcomes.

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Who is running the clinical trial?

Panbela Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
79 Total Patients Enrolled
Michael J Walker, MDStudy DirectorPanbela Therapeutics, Inc.

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05254171 — Phase 2 & 3
Pancreatic Cancer Research Study Groups: Control Arm, Experimental Arm
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05254171 — Phase 2 & 3
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254171 — Phase 2 & 3
~312 spots leftby Aug 2026