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RecruitingLast updated:19 September 2023

ASCEND: This phase II study is trying to understand the effectiveness of combining a new drug (CEND-1), compared to a placebo, with chemotherapy (gemcitabine and nab-paclitaxel) in people with untreated metastatic pancreatic cancerA Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Clinical summary

Summary

This is a double-blind trial and eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive nab-paclitaxel (125mg/m2 intravenously [IV]); CEND-1 (3.2mg/kg IV), and gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle. In the Placebo Comparator Arm, participants will receive nab-paclitaxel (125mg/m2); placebo (IV); and then Gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle.

Age

People18+

Phase

II

Trial Acronym

ASCEND

More information

Trial Identifiers

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Commercial Sponsor

University of Sydney, Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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