Evaluating the Utility of the Apoptosis Imaging Biomarker... | NCT01476085

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

NCT01476085

Sponsor

GlaxoSmithKline

Status

Terminated

Last Update Posted

Jul 1, 2013Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Cancer

Interventions

ML10

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 1, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2013

Last Update Posted Date

Jul 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
no treatment	No Intervention	no treatment	Radiation: ML10

Name	Type	Description	Arm Group Labels	Other Names
ML10	Radiation	[18F]ML10 radioligand apoptosis biomarker	no treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in [18F]ML10 uptake in tumours	Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.	between baseline at day 0 and between 14-20 days after

Secondary Outcomes

Measure	Description	Time Frame
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes	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.	between baseline at day 0 and between 14-20 days after

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
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
A female subject is eligible to participate if she has non-childbearing potential
Male subject must agree to use one of the contraception methods listed
Able to lie comfortably on back for up to 70 minutes at a time.
WHO performance status 0, 1 or 2 -

Exclusion Criteria:

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

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided