What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, particularly those similar to the ones being studied in the SBP-101 trial, include nab-paclitaxel and gemcitabine. Known side effects of these treatments include neutropenia, fatigue, neuropathy, and gastrointestinal issues such as nausea and diarrhea. Specifically, nab-paclitaxel combined with gemcitabine has been associated with higher rates of neutropenia, febrile neutropenia, fatigue, diarrhea, and neuropathy compared to gemcitabine alone.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including gemcitabine-based regimens. Gemcitabine alone was approved based on its ability to improve clinical benefit and survival. Combination therapies such as gemcitabine with nab-paclitaxel have shown superior efficacy compared to gemcitabine alone, with higher response rates and longer median survival. Another notable regimen is FOLFIRINOX, which includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, and has demonstrated significant survival benefits. These treatments are palliative and aim to improve symptoms and prolong survival in patients with metastatic pancreatic cancer.

What other types of research exist?

Promising novel alternatives to SBP-101 for pancreatic cancer patients include AZD1152-HQPA, which enhances the effectiveness of gemcitabine, and R115777, a farnesyltransferase inhibitor showing clinical activity against pancreatic cancer. Additionally, combination therapies involving nab-paclitaxel and gemcitabine are also being explored.

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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing a new drug called SBP-101 combined with two existing cancer drugs, nab-paclitaxel and gemcitabine, in patients with advanced pancreatic cancer. The goal is to see if adding SBP-101 can help these patients live longer and improve their quality of life. SBP-101 might work by making cancer cells easier to kill with the other drugs.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Progression Free Survival (PFS)

Other study objectives

Disease Control Rate (DCR)

Duration of Response (DoR)

Exploratory

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 14Eligibility criteria met

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.