Trial summary: This phase II study is trying to understand the effectiveness of combining a new drug (CEND-1), compared to a placebo, with chemotherapy (gemcitabine and nab-paclitaxel) in people with untreated metastatic pancreatic cancer.
Status: COMPLETED - Not Recruiting
Trial identifier: ACTRN12621001290886
Sponsor: University of Sydney, Australasian Gastro-Intestinal Trials Group (AGITG)
Phase: II
Diagnosis: Metastatic (Stage IV) pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: Gemcitabine and nab‐paclitaxel with CEND‐1/LSTA1 or placebo
  • Key inclusion criteria
    1. Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
    2. Measurable disease according to RECIST 1.1.
    3. Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
    4. ECOG performance of 0-1.
    5. Adequate renal and haematological function.
    6. Adequate hepatic function.
    7. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
    8. Study treatment both planned and able to start within 7 days after randomisation.
    9. Signed, written informed consent.
  • Key exclusion criteria
    1. 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.
    2. 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.
    3. Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.
    4. Any unresolved toxicity greater than or equal to 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 greater than or equal to Grade peripheral neuropathy are not allowed.
    5. Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents.
    6. Known allergy or hypersensitivity to any of the study drugs and excipients.
    7. 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, provided evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
    8. 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 greater than or equal to 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.
    9. Concurrent illness, including severe infection, that may jeopardise the ability of the person to undergo the procedures outlined in this protocol with reasonable safety.
    10. Neuroendocrine pancreatic carcinoma.
    11. Life expectancy of less than 3 months.
    12. 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.
    13. Serious medical or psychiatric conditions that might limit the ability of the person to comply with the protocol.

ASCEND

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill).

Epworth PI: Dr Ross Jennens

Jreissati Pancreatic Centre at Epworth 

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