An Extension Study of LON002 in Patients With Cancer

Solid Tumours Clinical Trial

Official title:

An Extension Study of LON002 in Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02390986
• Other study ID #: LON002-003
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 11, 2015
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2015
• Source: LondonPharma Ltd.
• Contact: David Laskow-Pooley
• Phone: 01865 784485
• Email: davidlaskow-pooley[@]londonpharma.com
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• LON002
Extension study to provide continuing access to LON002 medication.

Locations

Country	Name	City	State
United Kingdom	The Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	Guy's and St Thomas NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
LondonPharma Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes