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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

April 13, 2022

Primary Completion Date

June 1, 2025

Study Completion Date

October 1, 2025

Conditions
Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancer
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.

Trial Locations (24)

575

Sunshine Coast University Hospital, Birtinya

2050

Chris O'Brien Lifehouse, Camperdown

2217

St George Hospital, Kogarah

2290

Lake Macquarie Private Hospital, Gateshead

2640

Border Medical Oncology, Albury

3004

The Alfred Hospital, Melbourne

3076

Northern Health, Epping

3084

Warringal Private Hospital, Heidelberg

3121

Epworth Healthcare, Richmond

3168

Monash Medical Centre, Clayton

4029

Royal Brisbane and Womens Hospital, Herston

4066

Icon Cancer Centre Wesley, Auchenflower

4215

ICON Cancer Centre, Gold Coast University Hospital, Southport

5011

Queen Elizabeth Hospital, Woodville South

6008

St John of God, Subiaco

6150

Fiona Stanley Hospital, Murdoch

Unknown

Calvary Mater Newcastle, Newcastle

Newcastle Private Hospital, Newcastle

Prince of Wales Hospital, Sydney

Flinders Medical Centre, Adelaide

Launceston General Hospital, Launceston

Frankston Hospital, Melbourne

Dunedin Hospital, Dunedin

Waikato Hospital, Hamilton

All Listed Sponsors
collaborator

University of Sydney

OTHER

lead

Australasian Gastro-Intestinal Trials Group

NETWORK