Overview

This trial has been completed.

Condition pancreatic cancer
Treatments imm-101, gemcitabine
Phase phase 2
Sponsor Immodulon Therapeutics Ltd
Start date June 2011
End date February 2015
Trial size 110 participants
Trial identifier NCT01303172, IMM-101-002

Summary

To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients in the control arm will receive normal standard of care - up to 12 cycles of Gemcitabine. Dosing of Gemcitabine is as per the normal orescribing information for pancreatic cancer.
gemcitabine Gemzar
Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks. Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks). Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol.
(Experimental)
Patients in the experiemental arm will recieve IMM-101 in addition the current standard of care, namely chemotherapy (Gemcitabine). The treatment regimen with IMM-101 will be every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter. For patients in the active group, chemotherapy (GEM) will begin at least 14 days after first dose of IMM-101. Chemotherapy plus IMM-101 will be offered until intolerable toxcity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).
imm-101 Heat killed whole cell Mycobacterium obuense, M. obuense
IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline. A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL)will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter. Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine.

Primary Outcomes

Measure
No clinically relevant deleterious effect of IMM-101 on safety and tolerability.
time frame: After 12 months or as clinically indicated

Secondary Outcomes

Measure
A clinically relevant improvement in one or more markers of disease status
time frame: 12 months or as clinically indicated
Immunological markers
time frame: 12 months or as clinically indicated

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV). - Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following: - WHO performance status of 0-2 - serum creatinine <140 μmol/L - white blood cell (WBC) count, including differential counts within the normal range - a life expectancy of >3 months from randomisation Exclusion Criteria: - acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas. - severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments. - any previous chemotherapy treatment for pancreatic cancer. - eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation. - clinical or CT evidence of central nervous system (CNS) metastases. - any previous treatment with IMM-101 or related mycobacterial immunotherapy. - serum albumin < 26 g/L. - C-reactive protein (CRP) > 70 mg/L. - radiotherapy in the 6 weeks prior to screening. - depot corticosteroids in the 6 weeks prior to screening. - chronic use of any systemic corticosteroids and/or immunosuppressant drugs within the 2-week period prior to the first administration of study drug - female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control (

Additional Information

Official title A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Principal investigator Angus Dalgleish, Professor
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Immodulon Therapeutics Ltd.