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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 weeks
Awards & highlights
ASPIRE Trial 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.
ASPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on a scan.
Select...
I am fully active or can carry out light work.
Select...
I am not pregnant, can use birth control during the study, and if male, will also use contraception.
ASPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 weeks
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 moreASPIRE 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
Find a Location
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken hydroxychloroquine (Plaquenil) before.My cancer can be measured on a scan.I have a lung condition like interstitial lung disease or pulmonary fibrosis.I have symptoms from cancer spread to my brain.I do not have an active HIV, hepatitis B, or C infection.I am fully active or can carry out light work.I have had a blood clot or blockage in my veins during screening.I am not pregnant, can use birth control during the study, and if male, will also use contraception.I had major surgery less than 4 weeks ago and haven't fully recovered.I have untreated metastatic pancreatic cancer diagnosed within the last 3 months.My blood, liver, and kidney functions meet the required levels.My cancer is a confirmed type of pancreatic cancer.I am 18 years old or older.I have tested positive for the BRCA gene mutation.I am willing to stop taking metformin for my diabetes during the study.I have a history of eye diseases affecting my vision.I have a specific type of pancreatic or islet-cell tumor.I am currently being treated for a serious infection.Your blood has low levels of a protein called albumin.Your heart's electrical activity should be within a certain range called QTc interval.I haven't had a heart attack or severe heart issues in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Experimental Arm
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the desired sample size for this research project?
"A total of 150 patients are needed for this clinical trial, and recruitment is happening at multiple locations including Froedtert Hospital & the Medical College of Wisconsin in Milwaukee, Wisconsin and HOPE Cancer Center of East Texas in Tyler, Texas."
Answered by AI
Are investigators currently looking for participants for this research?
"This trial, as shown on clinicaltrials.gov, is looking for participants. The trial was announced on 8/8/2022 and has been updated as recently as 8/25/2022."
Answered by AI
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