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

NCT05042128 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2024-10-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LSTA1

LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC

DRUG

Gemcitabine Injection

Chemotherapy drug provided as solution to be administered via IV infusion.

DRUG

Nab paclitaxel

Chemotherapy drug provided as solution to be administered via IV infusion.

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Andrew Dean · St John of God Hospital

  • Timothy Price · The Queen Elizabeth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2025-06-01
Completion
2025-10-01

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042128 on ClinicalTrials.gov