Status:
TERMINATED
PET Study to Study Tumour Apoptosis
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Imperial College London
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. A bio...
Eligibility Criteria
Inclusion
- Male or female patients \>18 years of age at screening with histological or cytological diagnosis of non-Hodgkin's lymphoma, small cell lung cancer, breast or ovarian cancer who have been worked up clinically (see below) and due to receive standard chemotherapy treatment, but enrolled prior to the initiation of chemotherapy.
- A female subject is eligible to participate if she is of non-childbearing potential or if she is of childbearing potential and agrees to use one of the contraception methods listed. Male subjects are eligible to participate if he also agrees to use one of the contraception methods listed.
- Tumour that is considered by the investigator to be able to be imaged using PET (about 2cm in size or more)
- Able to lie comfortably on back for up to 65 minutes at a time.
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- Patients deemed to be fit to receive chemotherapy treatment by their oncologist.
- WHO performance status 0, 1 or 2.
Exclusion
- Any medical or psychiatric diagnoses or symptoms or social situations that in the view of the investigator would limit compliance with study requirements.
- Pregnant or breast feeding females.
- Received any other anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) or any other investigational agent, including an investigational anti-cancer agent within 28 days prior to the first \[18F\]ML10-PET scan.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to comply with contraceptive guidelines during the study.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01428440
Start Date
December 1 2009
End Date
July 1 2011
Last Update
January 12 2017
Active Locations (2)
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1
GSK Investigational Site
London, London, United Kingdom, W12 0NN
2
GSK Investigational Site
London, United Kingdom, SE1 9RT