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The ASCEND Study: Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma (ASCEND)

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ClinicalTrials.gov Identifier: NCT05042128
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Collaborator:
Australasian Gastro-Intestinal Trials Group
Information provided by (Responsible Party):
University of Sydney

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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Cancer Drug: CEND-1 Drug: Gemcitabine Injection Drug: Nab paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024


Arm Intervention/treatment
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.
Drug: 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
Other Name: iRGD

Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Name: Gemzar

Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Name: Abraxane

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.
Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Name: Gemzar

Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Name: Abraxane




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From date of randomization to 18 months later, or death ]
    Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomization to 18 months later, or death ]
    Period of time from randomization to date of death from any cause, or the date of last known follow-up alive

  2. Objective Tumour Response Rate [ Time Frame: From date of randomization to 18 months later, or death ]
    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

  3. Patient-reported Outcomes [ Time Frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months). ]
    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).

  4. Patient-reported Outcomes [ Time Frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months). ]
    Completion of the QLQ-PAN26 questionnaire. 26 questions on a 1-4 scale (Higher scores indicative of poorer quality of life)

  5. Incidence of Treatment-Emergent Adverse Events (Patient Safety) [ Time Frame: From date of randomization until 30 days after final treatment visit ]
    Record of all adverse events (including SAEs) that patients experience



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05042128


Contacts
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Contact: Nathan Bradshaw +61280365270 ascend.study@sydney.edu.au

Locations
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Australia, South Australia
Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Contact: Pamela Cooper         
Principal Investigator: Timothy Price         
Australia, Western Australia
St John of God
Subiaco, Western Australia, Australia, 6008
Contact: Taryn Quartermaine         
Contact    618 6465 2750      
Principal Investigator: Andrew Dean         
Sponsors and Collaborators
University of Sydney
Australasian Gastro-Intestinal Trials Group
Investigators
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Study Chair: Andrew Dean St John of God Hospital
Study Chair: Timothy Price The Queen Elizabeth Hospital
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.

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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT05042128    
Other Study ID Numbers: CTC0304
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs