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RecruitingLast updated: 23 May 2024

ASCEND: 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 cancerA Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Clinical summary

Summary

This is a double-blind trial and eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive nab-paclitaxel (125mg/m2 intravenously [IV]); CEND-1 (3.2mg/kg IV), and gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle. In the Placebo Comparator Arm, participants will receive nab-paclitaxel (125mg/m2); placebo (IV); and then Gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle.

Conditions

This trial is treating patients with pancreatic cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

ASCEND

More information

Trial Identifiers

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Trial sponsor

University of Sydney,Australasian Gastro-Intestinal Trials Group (AGITG)

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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