Overview

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

Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Sydney
Collaborator:
Australasian Gastro-Intestinal Trials Group
Treatments:
Gemcitabine
Paclitaxel
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.