G1T28-02_Phase 1b/2a Safety and PK Study of G1T28 (3652_0004)
Research type
Research Study
Full title
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin Chemotherapy
IRAS ID
208844
Contact name
Pieter Postmus
Contact email
Sponsor organisation
G1 Therapeutics
Eudract number
2016-001583-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 12 days
Research summary
Chemotherapy-induced myelosuppression (decrease in the ability of the bone marrow to produce blood cells) is a significant issue in cancer treatment. It continues to represent the major dose-limiting toxicity (DLT) of cytotoxic chemotherapy, including the etoposide and platinum (cisplatin or carboplatin) combination used to treat extensive stage small Cell Lung Cancer (SCLC), an aggressive (fast-growing) cancer that forms in tissues of the lung and can spread to other parts of the body.\n\nThis is a randomised, double-blind, placebo-controlled, multicentre Phase 1b/2a study to assess the safety and tolerability of combining G1T28 with etoposide and carboplatin therapy (E/P therapy) and to evaluate the effect of G1T28 on blood cell production affected by chemotherapy in patients with newly diagnosed extensive-stage (SCLC). The study consists of 2 parts.\n\nPart 1 will be open label; meaning every patient in part 1 will receive G1T28. There will be a Phase 1b, dose-finding portion followed by a Phase 2a, expansion portion at the selected dose to be used in Part 2. In Part 2, 70 patients will be randomly assigned to G1T28 administered Intravenous (IV) with E/P therapy or placebo administered IV with E/P therapy. \n\nStudy drug administration will continue for each patient until disease progression per Response Evaluation Criteria In Solid Tumours (RECIST), unacceptable toxicity, withdrawal of consent, or discontinuation by investigator (eg, after completing 6 cycles), whichever occurs first. RECIST is a set of published rules that define how tumors respond to treatment.\nThe total study duration is at least 29 months. This study will involve about 110 patients at about 80 different centres in North America and Europe. Part 1 of the study will involve about 6 to 40 patients. Part 2 of the study will involve about 70 patients.\n\nUK will not participate in Part 1 Phase 1b, open-label, dose-finding portion\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0725
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion