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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05042128




Registration number
NCT05042128
Ethics application status
Date submitted
25/08/2021
Date registered
13/09/2021

Titles & IDs
Public title
The ASCEND Study: Gemcitabine and Nab-Paclitaxel With CEND-1/LSTA1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Scientific title
A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1/LSTA1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 0 0
CTC0304
Universal Trial Number (UTN)
Trial acronym
ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma 0 0
Metastatic Pancreatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CEND-1/LSTA1
Treatment: Drugs - Gemcitabine Injection
Treatment: Drugs - Nab paclitaxel

Experimental: Cohort A: Standard Care + CEND1/LSTA1 (1 dose) - Participants will receive nab-paclitaxel 125mg/m2; CEND1/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.

Placebo comparator: Cohort A: Standard Care + Placebo - Participants 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.

Experimental: Cohort B: Standard Care + CEND1/LSTA1 (2 doses) - Participants will receive nab-paclitaxel 125mg/m2; CEND1/LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +\~4hrs CEND-1/LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.

Placebo comparator: Cohort B: Standard Care + Placebo - Participants 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.


Treatment: Drugs: CEND-1/LSTA1
CEND-1/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

Treatment: Drugs: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.

Treatment: Drugs: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [2] 0 0
Objective Tumour Response Rate
Timepoint [2] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [3] 0 0
Patient-reported Outcomes
Timepoint [3] 0 0
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Secondary outcome [4] 0 0
Patient-reported Outcomes
Timepoint [4] 0 0
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Secondary outcome [5] 0 0
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
Timepoint [5] 0 0
From date of randomization until 30 days after final treatment visit

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
* Any unresolved toxicity NCI CTCAE Grade =2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and the laboratory values defined in the inclusion criteria. Participants with Grade =2 peripheral neuropathy are not allowed.
* 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:

1. Malignancy that was treated with curative intent and for which there has been no known active disease for =2 years prior to randomisation.
2. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [5] 0 0
St George Hospital - Kogarah
Recruitment hospital [6] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [7] 0 0
Newcastle Private Hospital - Newcastle
Recruitment hospital [8] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [9] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [10] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [12] 0 0
ICON Cancer Centre, Gold Coast University Hospital - Southport
Recruitment hospital [13] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [14] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [15] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [16] 0 0
Northern Health - Epping
Recruitment hospital [17] 0 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [18] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [20] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [21] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [22] 0 0
St John of God - Subiaco
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
2290 - Gateshead
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
- Newcastle
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower
Recruitment postcode(s) [9] 0 0
575 - Birtinya
Recruitment postcode(s) [10] 0 0
4029 - Herston
Recruitment postcode(s) [11] 0 0
4215 - Southport
Recruitment postcode(s) [12] 0 0
- Adelaide
Recruitment postcode(s) [13] 0 0
5011 - Woodville South
Recruitment postcode(s) [14] 0 0
- Launceston
Recruitment postcode(s) [15] 0 0
3076 - Epping
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment postcode(s) [18] 0 0
- Melbourne
Recruitment postcode(s) [19] 0 0
3121 - Richmond
Recruitment postcode(s) [20] 0 0
6150 - Murdoch
Recruitment postcode(s) [21] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Dunedin
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Dean
Address 0 0
St John of God Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05042128