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A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer


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 ╬╝mol/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 (

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

No clinically relevant deleterious effect of IMM-101 on safety and tolerability.

Outcome Description:

A clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles will be judged by: Local and systemic toxicities. Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).Efficacy will be defined as a clinically relevant improvement in one or more markers of disease status.

Outcome Time Frame:

After 12 months or as clinically indicated

Safety Issue:

Yes

Principal Investigator

Angus Dalgleish, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

St George's, University of London

Authority:

Italy: Ministry of Health

Study ID:

IMM-101-002

NCT ID:

NCT01303172

Start Date:

June 2011

Completion Date:

April 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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