Nab-Paclitaxel + Gemcitabine +/- SBP-101 for Pancreatic Cancer
(ASPIRE Trial)
Recruiting in Palo Alto (17 mi)
+86 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Panbela Therapeutics, Inc.
Must be taking: Nab-paclitaxel, Gemcitabine
Must not be taking: Metformin, Hydroxychloroquine
Disqualifiers: BRCA mutations, Retinopathy, CNS metastasis, others
Stay on Your Current Meds
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop taking metformin (a diabetes medication) at least 5 days before starting the study and not use it during the trial. Other diabetic medications are allowed, but the protocol does not specify about other medications.
What data supports the effectiveness of the drug Nab-Paclitaxel + Gemcitabine +/- SBP-101 for Pancreatic Cancer?
Research shows that combining nab-paclitaxel (a form of chemotherapy) with gemcitabine significantly improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This combination has become a standard treatment option for metastatic pancreatic cancer due to its demonstrated effectiveness.
12345Is the combination of Nab-Paclitaxel and Gemcitabine safe for treating pancreatic cancer?
The combination of Nab-Paclitaxel and Gemcitabine for pancreatic cancer has been studied and generally has a manageable safety profile. Common side effects include neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage), which were mostly mild and resolved with treatment adjustments.
14567What makes the drug combination of nab-paclitaxel, gemcitabine, and SBP-101 unique for pancreatic cancer?
This drug combination is unique because it includes nab-paclitaxel, a novel formulation of paclitaxel that avoids certain toxicities, and is combined with gemcitabine, a standard treatment for pancreatic cancer, potentially enhancing effectiveness. The addition of SBP-101, which is not commonly used in standard regimens, may offer a new approach to treatment.
12458Eligibility Criteria
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.Inclusion Criteria
My cancer can be measured on a scan.
I am fully active or can carry out light work.
I am not pregnant, can use birth control during the study, and if male, will also use contraception.
+7 more
Exclusion Criteria
Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.
I have taken hydroxychloroquine (Plaquenil) before.
I have a lung condition like interstitial lung disease or pulmonary fibrosis.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive nab-paclitaxel and gemcitabine with or without SBP-101
Up to 100 weeks
Regular visits as per protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Participant Groups
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.
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
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇺🇸 Approved in United States as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇨🇦 Approved in Canada as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇯🇵 Approved in Japan as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical Oncology Associates - SpokaneSpokane, WA
Froedtert Hospital & the Medical College of WisconsinMilwaukee, WI
Medical Oncology AssociatesSpokane, WA
Columbia University Medical CenterNew York, NY
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Panbela Therapeutics, Inc.Lead Sponsor
References
nab-Paclitaxel for the treatment of pancreatic cancer. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Nanoparticle albumin-bound paclitaxel (nab-P) plus gemcitabine (Gem) became a standard treatment option for metastatic pancreatic cancer (MPC) following positive results from a global phase III trial (MPACT). A large number of studies have now published results on the use of nab-P/Gem to treat advanced and early-stage disease, warranting a comprehensive review. The main goal of this systematic review is to summarize the efficacy and safety data of nab-P/Gem for the treatment of pancreatic cancer (PC).
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]Substantial antitumor activity has previously been demonstrated with the addition of nab-paclitaxel (Abraxane [Celgene, Summit, NJ]), an albumin-bound formulation of paclitaxel, to gemcitabine in patients with advanced pancreatic cancer. Given preclinical evidence of synergy when a fluoropyrimidine is added to gemcitabine plus a taxane in a sequence-specific schedule, we conducted a phase I study to evaluate the combination of nab-paclitaxel, gemcitabine, and capecitabine administered biweekly in patients with metastatic pancreatic adenocarcinoma.
Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2. [2022]Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and a Karnofsky performance status (PS) of 70% or greater. Because of the low number of patients with reduced PS, the efficacy of this regimen in fragile patients remains unclear. This study aimed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS.
Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute. [2022]Paclitaxel albumin-bound particles (nab-paclitaxel, ABRAXANE) (nab-P) improve outcomes when compared against single agent cremophor-based paclitaxel, as do the addition of bevacizumab (B) or gemcitabine (G) to the same agent. There are no available data regarding combinations of nab-P with B and/or G. Ongoing investigational efforts are evaluating various doublets with these agents, but, to the best of our knowledge, not all 3 of them in the same regimen. All drugs are currently FDA-approved in the treatment of cancer.
A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. [2022]The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus gemcitabine (GEM) in elderly Japanese patients with pancreatic cancer remain unclear. Therefore, we prospectively investigated the tolerability and efficacy of nab-PTX + GEM in Japanese patients aged ≥ 75 years with non-curatively resectable pancreatic cancer.
Albumin-bound paclitaxel: a review of its use for the first-line combination treatment of metastatic pancreatic cancer. [2021]Nanoparticle albumin-bound paclitaxel (Abraxane(®)) [hereafter referred to as nab-paclitaxel] is an intravenously administered microtubule inhibitor. It was developed to avoid the toxicities associated with the polyoxyethylated castor oil solvent (Cremophor) and ethanol vehicles used to overcome paclitaxel's poor aqueous solubility. Nab-paclitaxel is indicated in the EU and the USA as first-line combination therapy with gemcitabine in adults with metastatic adenocarcinoma of the pancreas. Compared with gemcitabine alone, nab-paclitaxel plus gemcitabine significantly prolonged median overall survival, reflecting a 28 % reduction in the risk of death, in adults with metastatic pancreatic cancer participating in a multinational phase III study. In addition, median progression-free survival was significantly prolonged and the objective response rate was significantly higher with nab-paclitaxel plus gemcitabine than with gemcitabine therapy. Nab-paclitaxel plus gemcitabine had a manageable tolerability profile; in general, adverse events in the phase III study were grade 3 or lower and resolved without specific therapy. Neutropenia and peripheral neuropathy were the most frequently reported adverse reactions leading to nab-paclitaxel dose reductions, or to delays in or the withholding of nab-paclitaxel dosing. Peripheral neuropathy was rapidly reversible in the majority of patients following interruptions in nab-paclitaxel administration and a subsequent reduction in the nab-paclitaxel dose. Current evidence indicates that nab-paclitaxel plus gemcitabine is a valuable option for the treatment of metastatic pancreatic cancer.
An in vitro and in vivo study of gemcitabine-loaded albumin nanoparticles in a pancreatic cancer cell line. [2022]Gemcitabine (Gem) is far from satisfactory as the first-line regimen for pancreatic cancer, and the emergence of albumin nanoparticles offers new hope for the delivery of Gem. In this study, Gem-loaded human serum albumin nanoparticles (Gem-HSA-NPs) were successfully synthesized, characterized, and tested on a BxPC-3 cell line both in vitro and in vivo.
Safety and efficacy evaluation of albumin-bound paclitaxel. [2015]Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe and the US; in combination therapy for non-small-cell lung cancer (NSCLC) and for first-line treatment of advanced pancreatic cancer (PC) only in the US. The European Medicines Agency has recently released only a positive opinion for use of nab-paclitaxel in PC.