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Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)

This study has been terminated.
(Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476085
First received: September 1, 2011
Last updated: June 27, 2013
Last verified: June 2013

September 1, 2011
June 27, 2013
July 2011
October 2011   (final data collection date for primary outcome measure)
changes in [18F]ML10 uptake in tumours [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
Same as current
Complete list of historical versions of study NCT01476085 on ClinicalTrials.gov Archive Site
  • alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
    Relationship between alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes in response to chemotherapy as measured by standard of care CT scan and FDG PET scan.
  • voxel-based uptake map of [18F]ML10 in the target lesion [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
    Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
Same as current
Not Provided
Not Provided
 
Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).

This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.

Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. In addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cancer
Radiation: ML10
[18F]ML10 radioligand apoptosis biomarker
No Intervention: no treatment
no treatment
Intervention: Radiation: ML10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
  2. Male or female patients >18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
  3. A female subject is eligible to participate if she has non-childbearing potential
  4. Male subject must agree to use one of the contraception methods listed
  5. Able to lie comfortably on back for up to 70 minutes at a time.
  6. WHO performance status 0, 1 or 2 -

Exclusion Criteria:

  1. Patients with known history of Hepatitis B, C, non-A, non-B and HIV
  2. Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
  3. Pregnant or breast feeding females.
  4. Any other prior anticancer therapy
  5. Any new investigational agent, including an investigational anti-cancer agent
  6. History of sensitivity to heparin or heparin-induced thrombocytopenia.
  7. Males and females not able to comply with contraceptive guidelines during the study.

    -

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01476085
114238
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP