STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial - STOMP: SCLC Trial of Olaparib (AZD2281) as Maintenance Programme.
- Conditions
- Small cell lung cancerMedDRA version: 16.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864
- Registration Number
- EUCTR2010-021165-76-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 222
•Pathologically confirmed SCLC (limited or extensive stage).
•Completed at least 3 cycles of first line chemotherapy with cisplatin or carbopatin + etoposide.
•Complete response or partial response to first line chemotherapy.
•ECOG performance status 0-2.
•Resolution of all treatment toxicity to grade 1 or better.
•Adequate physiological function:
•renal: calculated or measured creatinine clearance greater than or equal to 50 ml/min, serum creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
•haematological: Haemoglobin greater than or equal to 9.0 g/dL, White blood cells (WBC)greater than 3x109/L, ANC greater than or equal to 1.5 x 109/L, Platelet count greater than or equal to 100 x 109/L.
•hepatic: AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional ULN unless liver metastases are present in which case it must be less than or equal to 5x ULN bilirubin within normal range, AST/ALT less than or equal to 1.5 x ULN.
•Negative pregnancy test and agrees to comply with contraceptive measures.
•Provision of written informed consent.
•Able to swallow oral medication
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Age greater than 18 years.
•Interval from last anticancer treatment to start of study treatment:
- radiotherapy less than 21 days
- chemotherapy less than 42 days
•Symptomatic brain metastases.
•Interstitial lung disease.
•Previous malignancies (except curatively treated non-melanoma skin cancer or
carcinoma in situ of the cervix or breast) within the past 3 years.
•History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
•Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
•Any previous treatment with a PARP inhibitor, including olaparib.
•Patients receiving the following classes of inhibitors of CYP3A4:
Azole antifungals
Macrolide antibiotics
Protease inhibitors
•Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
•Breast feeding women.
•Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
•Patients with known active hepatic disease (i.e., Hepatitis B or C).
•Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
•Patients with uncontrolled seizures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method