An Extension Study of LON002 in Patients With Cancer

Not Applicable

• Conditions: Solid Tumours

• Registration Number: NCT02390986
• Lead Sponsor: LondonPharma Ltd.

Brief Summary

The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.

Detailed Description

This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.

Long term safety and efficacy will be evaluated.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-11
• Last Update Submitted: 2015-03-11
• Study First Posted: 2015-03-18
• Last Update Posted: 2015-03-18
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Written informed consent;
2. Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
3. Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
4. Able to comply with the protocol LON002-003;
5. Women of child bearing potential must have a negative pregnancy test before the start of treatment;
6. Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
7. Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter

Exclusion Criteria

1. Has not completed a LondonPharma sponsored parent trial of LON002;
2. Unequivocal evidence of disease progression;
3. Unacceptable toxicity experienced in the parent trial;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

The Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom

Guy's and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom