An Extension Study of LON002 in Patients With Cancer
1 other identifier
interventional
50
1 country
2
Brief Summary
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 18, 2015
March 1, 2015
2.4 years
March 2, 2015
March 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
Participants will be followed for the duration of their study treatment, an expected average of 6 months
Interventions
Extension study to provide continuing access to LON002 medication.
Eligibility Criteria
You may qualify if:
- Written informed consent;
- Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
- Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
- Able to comply with the protocol LON002-003;
- Women of child bearing potential must have a negative pregnancy test before the start of treatment;
- Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
- Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter
You may not qualify if:
- Has not completed a LondonPharma sponsored parent trial of LON002;
- Unequivocal evidence of disease progression;
- Unacceptable toxicity experienced in the parent trial;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Debashis Sarker, MD
Guy's and St Thomas' NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Mazhar Ajaz, MD
Royal Surrey County Hospital NHS Trust
- STUDY DIRECTOR
Daryl Bendel, MD
Xidea Solutions Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 18, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 18, 2015
Record last verified: 2015-03