An Extension Study of LON002 in Patients With Cancer

LondonPharma

Status: Unknown

Conditions: Solid Tumours

Treatments: Drug: LON002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390986

LON002-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)