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. ^{1 2 3 4 5}

Is 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. ^{1 4 5 6 7}

What 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. ^{1 2 4 5 8}

Research Team

Michael J Walker, MD

Principal Investigator

Panbela Therapeutics, Inc.

Eligibility 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.

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.

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

Treatment Details

Interventions

• Gemcitabine (Anti-metabolites)
• Nab-paclitaxel (Anti-metabolites)
• SBP-101 (Other)

Trial Overview 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.

Participant Groups

Group I: Experimental Arm Experimental Treatment 3 Interventions

SBP-101 + Nab-paclitaxel and Gemcitabine

Group II: Control Arm Placebo Group 3 Interventions

Placebo + Nab-Paclitaxel and Gemcitabine

Gemcitabine is already approved in Canada, Japan for the following indications:

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

Who Is Running the Clinical Trial?

Panbela Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

680+

Findings from Research

Nab-paclitaxel plus gemcitabine (nab-P/Gem) is an effective first-line treatment for metastatic pancreatic cancer, with median overall survival rates ranging from 8.7 to 13.5 months across various studies involving a diverse patient population.

The combination of nab-P/Gem with additional agents is being actively researched, showing promise for improving outcomes in advanced pancreatic cancer, with median overall survival extending up to 17 months in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nab-Paclitaxel for the treatment of pancreatic cancer. Kim, G.[2023]

The combination of nab-paclitaxel, gemcitabine, and capecitabine was found to be well tolerated in a phase I study with 15 patients, establishing a maximum-tolerated dose (MTD) but showing only modest antitumor activity in metastatic pancreatic cancer.

Despite the regimen being generally safe, with a low incidence of severe hematologic toxicities, only 14.3% of patients had a partial response, indicating that optimizing dose intensity may be crucial for improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. Ko, AH., Truong, TG., Kantoff, E., et al.[2022]

In a study involving 221 patients with metastatic pancreatic ductal adenocarcinoma and poor performance status, the combination of NAB-paclitaxel and gemcitabine was found to be well tolerated, with manageable side effects such as anemia and neutropenia.

Both dosing regimens of NAB-paclitaxel (100 mg/m2 and 125 mg/m2) showed similar efficacy, with comparable response rates and median progression-free survival, indicating that this treatment is effective for fragile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Macarulla, T., Pazo-Cid, R., Guillén-Ponce, C., et al.[2022]

In a small study of 6 women with heavily pretreated HER2-negative metastatic breast cancer, the combination of nab-paclitaxel (nab-P) and bevacizumab (B), with or without gemcitabine (G), showed promising safety and preliminary efficacy, with only one patient experiencing significant toxicity.

Out of the 6 patients, 2 achieved partial responses and 4 had stable disease, indicating that this combination therapy may be effective, warranting further investigation in a formal phase II trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lobo, C., Lopes, G., Silva, O., et al.[2022]

In a study of 27 elderly Japanese patients (aged ≥ 75) with non-curatively resectable pancreatic cancer, the combination of nanoparticle albumin-bound paclitaxel (nab-PTX) and gemcitabine (GEM) showed a high disease control rate of 92.6%, indicating strong efficacy in managing the disease.

Despite its effectiveness, the treatment was associated with significant adverse effects, including a 51.9% incidence of grade 3 or higher hemotoxicity and a 22% rate of grade ≥ 3 peripheral nerve disorders, highlighting the need for careful monitoring and dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. Hasegawa, R., Okuwaki, K., Kida, M., et al.[2022]

Gemcitabine-loaded human serum albumin nanoparticles (Gem-HSA-NPs) were successfully developed and showed a favorable controlled release, with an encapsulation rate of approximately 83% and a particle size of about 150 nm.

In vivo studies demonstrated that Gem-HSA-NPs significantly inhibited tumor growth in pancreatic cancer while exhibiting lower toxicity compared to other treatment groups, indicating their potential as a safer and more effective delivery method for gemcitabine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vitro and in vivo study of gemcitabine-loaded albumin nanoparticles in a pancreatic cancer cell line. Yu, X., Di, Y., Xie, C., et al.[2022]

Nab-paclitaxel, a new formulation of paclitaxel, has shown a good safety and efficacy profile for treating metastatic breast cancer (MBC), although there is limited data on its impact on overall survival.

In combination with gemcitabine, nab-paclitaxel significantly improves survival in advanced pancreatic cancer (PC) and demonstrates better results in non-small-cell lung cancer (NSCLC) patients with squamous histology, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. Cecco, S., Aliberti, M., Baldo, P., et al.[2015]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

nab-Paclitaxel for the treatment of pancreatic cancer. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. France pubmed.ncbi.nlm.nih.gov

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]

5. Japan pubmed.ncbi.nlm.nih.gov

A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Albumin-bound paclitaxel: a review of its use for the first-line combination treatment of metastatic pancreatic cancer. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

An in vitro and in vivo study of gemcitabine-loaded albumin nanoparticles in a pancreatic cancer cell line. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. [2015]