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Trial details imported from ClinicalTrials.gov

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




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

Titles & IDs
Public title
The ASCEND Study: Gemcitabine and Nab-Paclitaxel With CEND-1 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 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
Treatment: Drugs - Gemcitabine Injection
Treatment: Drugs - Nab paclitaxel

Experimental: Standard Care + CEND1 - Participants will receive nab-paclitaxel 125mg/m2; CEND1 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: 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.


Treatment: Drugs: CEND-1
CEND-1 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 - Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
Timepoint [1] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [1] 0 0
Overall Survival - Period of time from randomization to date of death from any cause, or the date of last known follow-up alive
Timepoint [1] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [2] 0 0
Objective Tumour Response Rate - The number of participants with documented partial or complete response (PR or CR) divided by the number of participants evaluable for response as defined as per the RECIST version 1.1 criteria
Timepoint [2] 0 0
From date of randomization to 18 months later, or death
Secondary outcome [3] 0 0
Patient-reported Outcomes - Completion of the EORTC QLQ-C30 questionnaire. 30 questions; 28 on a 1-4 scale (Higher scores indicative of poorer quality of life), 2 on a 1-7 scale (higher scores indicative of better health/quality of life).
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 - Completion of the QLQ-PAN26 questionnaire. 26 questions on a 1-4 scale (Higher scores indicative of poorer quality of life)
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) - Record of all adverse events (including SAEs) that patients experience
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
Gender
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
St John of God - Subiaco
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
6008 - Subiaco

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the ASCEND clinical trial is to measure the effect of adding CEND-1, 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 website
https://clinicaltrials.gov/show/NCT05042128
Trial related presentations / publications
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.
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
Nathan Bradshaw
Address 0 0
Country 0 0
Phone 0 0
+61280365270
Fax 0 0
Email 0 0
ascend.study@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05042128