Acelarin First Line Randomised Pancreatic Study

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess whether Acelarin (NUC-1031) is superior to gemcitabine in terms of overall survival for treatment of patients with metastatic pancreatic carcinoma. In addition disease progression, quality of life and comparative safety will be evaluated. Secondary objectives are to compare between the two treatment groups the following:

• Progression Free Survival (PFS)

• Radiological Response and disease control rate

• Toxicity and safety

• Quality of Life

Additional, exploratory objectives are to discover and validate possible biomarkers to predict additional benefit of Acelarin (NUC-1031) over gemcitabine alone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust
• Collaborators: Cancer Research UK; University of Liverpool
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.

• Metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected pancreatic cancer can be included.

• Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment.

• Unidimensionally measurable disease.

• ECOG performance status 0, 1 or 2 where combination chemotherapy is not deemed appropriate or is declined by the patient.

• Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry.

• Documented life expectancy > 3 months.

• Informed written consent.

Exclusion Criteria:

• Laboratory results:

• Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR).

• Haemoglobin < 10G/dl.

• Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula).

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULN or > 5x ULN if judged by the investigator to be related to liver metastases.

• Medical or psychiatric conditions compromising informed consent.

• Intracerebral metastases or meningeal carcinomatosis.

• Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.

• Pregnancy or breast feeding.

• Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously.

• Radiotherapy within the last 4 weeks prior to start of study treatment.

• Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer.

• Hypersensitivity to gemcitabine or any of the excipients of gemcitabine or Acelarin (NUC-1031).

• All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be from the list below, the other must be a condom* or abstaining from sexual intercourse, until six months after treatment has ended:

• Combined (oestrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: either oral, intravaginal or transdermal.

• Progesterone-only hormonal contraception associated with inhibition of ovulation:

either oral, injectable or implantable.

• Intra-uterine device (IUD)

• Intra-uterine hormone-releasing system (IUS)

• Bilateral tubal occlusion

• Vasectomised partner *Male or female condom with or without spermicide is not an acceptable method of contraception alone.