The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
ASCEND
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
1 other identifier
interventional
158
2 countries
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedOctober 22, 2024
April 1, 2024
3.1 years
August 25, 2021
October 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
From date of randomization to 18 months later, or death
Secondary Outcomes (5)
Overall Survival
From date of randomization to 18 months later, or death
Objective Tumour Response Rate
From date of randomization to 18 months later, or death
Patient-reported Outcomes
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Patient-reported Outcomes
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
From date of randomization until 30 days after final treatment visit
Study Arms (4)
Cohort A: Standard Care + LSTA1 (1 dose)
EXPERIMENTALParticipants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Cohort A: Standard Care + Placebo
PLACEBO COMPARATORParticipants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Cohort B: Standard Care +LSTA1 (2 doses)
EXPERIMENTALParticipants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +\~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Cohort B: Standard Care + Placebo
PLACEBO COMPARATORParticipants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +\~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Interventions
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
Chemotherapy drug provided as solution to be administered via IV infusion.
Chemotherapy drug provided as solution to be administered via IV infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy or biological agents.
- Known allergy or hypersensitivity to any of the study drugs and excipients.
- Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
- History of prior or synchronous malignancy within 2 years prior to randomisation, except:
- Malignancy that was treated with curative intent and for which there has been no known active disease for ≥2 years prior to randomisation.
- Curatively treated non-melanoma skin cancer, cervical cancer in situ, superficial transitional cell carcinoma of the bladder, stage 1 endometrial carcinoma, prostatic intraepithelial neoplasia, low-grade papillary thyroid cancer, untreated localised very low risk or low risk prostate cancer under observation.
- Concurrent illness, including severe infection that may jeopardise the ability of the person to undergo the procedures outlined in this protocol with reasonable safety.
- Neuroendocrine pancreatic carcinoma.
- Life expectancy of less than 3 months.
- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception.
- Serious medical or psychiatric conditions that might limit the ability of the person to comply with the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Australasian Gastro-Intestinal Trials Grouplead
- University of Sydneycollaborator
Study Sites (24)
Border Medical Oncology
Albury, New South Wales, 2640, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Monash Medical Centre
Clayton, New South Wales, 3168, Australia
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290, Australia
St George Hospital
Kogarah, New South Wales, 2217, 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, 4066, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 575, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
ICON Cancer Centre, Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Northern Health
Epping, Victoria, 3076, Australia
Warringal Private Hospital
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Frankston Hospital
Melbourne, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, 3121, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
St John of God
Subiaco, Western Australia, 6008, Australia
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Related Publications (1)
Dean A, Gill S, McGregor M, et al. 1528P Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. Annals of Oncology 2020; 31: S941.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew Dean
St John of God Hospital
- STUDY CHAIR
Timothy Price
The Queen Elizabeth Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
September 13, 2021
Study Start
April 13, 2022
Primary Completion
June 1, 2025
Study Completion
October 1, 2025
Last Updated
October 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share