GEMIN X (GEM 017) Obatoclax in Extensive Small Cell Lung Cancer
Research type
Research Study
Full title
A Phase I Followed By A Randomised, Phase II Study Of Carboplatin And Etoposide With Or Without Obatoclax Administered Every 3 Weeks To Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
IRAS ID
11135
Sponsor organisation
Gemin X Pharmaceuticals US Inc.
Eudract number
2008-001679-31
Clinicaltrials.gov Identifier
Research summary
Small cell lung cancer is an aggressive malignancy associated with a dismal prognosis of 2-5% at 2 years. There has been no major improvement in therapy over the last two decades. New effective treatment is therefore urgently required. Obatoclax is a new drug that is being developed by the company Gemin X. Obatoclax is a type of drug known to be an inhibitor of proteins needed for cancer cell survival. How obatoclax works is not completely known, but it is believed to cause cancer cells to die. If all cancer cells die, then the disease should improve; if they do not die, the disease will not improve. Obatoclax is currently being assessed in multiple Phase 1 and Phase 2 clinical studies directed against multiple solid tumor and hematologic malignancies. This trial aims to compare the Effectiveness of obatoclax given with carboplatin and etoposide against carboplatin and etoposide given alone. This will be done by measuring the response of patients when given, or not given, obatoclax. Patients with Extensive Stage Small Cell Lung Cancer will be randomly allocated to one of 2 groups in the Phase 2 part of the study. The first group is to receive obatoclax in a 3 hr infusion on 3 consecutive days. This group will also receive the standard treatment for this disease. The second group will receive the standard treatment for this disease alone. No patients will be enrolled in the Phase I part of the study in Europe as the Phase I is being conducted in the US.
REC name
HSC REC B
REC reference
09/NIR02/6
Date of REC Opinion
20 Feb 2009
REC opinion
Further Information Favourable Opinion