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The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

NCT05042128•Australasian Gastro-Intestinal Trials Group

View on ClinicalTrials.gov

Summary

The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
•Measurable disease according to RECIST 1.1.
•Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
•ECOG performance of 0-1 (Appendix 2)
•Adequate renal and haematological function
•Adequate hepatic function, defined as:
•Bilirubin \<1.5 X ULN (Upper Limit of Normal), AST or ALT ≤ 5x ULN. If a person was recently stented with improving bilirubin, the person can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
•Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
•Study treatment both planned and able to start within 7 days after randomisation
•Signed, written informed consent.
+11 more criteria

Exclusion Criteria

•Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time.
•Prior chemotherapy or investigational anti-cancer therapy for metastatic pancreatic adenocarcinoma. Prior treatments with curative intent or for locally advanced disease are allowed, provided the last dose of chemotherapy was administered more than 6 months prior to randomisation.
•Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.

Locations (24)

Border Medical Oncology

Albury, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Monash Medical Centre

Clayton, New South Wales, Australia

Lake Macquarie Private Hospital

Gateshead, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Newcastle Private Hospital

Newcastle, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Key Dates

Start Date

April 13, 2022

Primary Completion Date

June 1, 2025

Completion Date

October 1, 2025

Last Updated

October 22, 2024

Enrollment

158

ACTUAL participants

Conditions

Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancer

Interventions

LSTA1

DRUG

Gemcitabine Injection

DRUG

Nab paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

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