E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041071 |
E.1.2 | Term | Small cell lung cancer stage unspecified |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the time it takes for the patient's cancer to get worse (tumour gets bigger) when treated with olaparib, as opposed to those patients that receive placebo. |
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E.2.2 | Secondary objectives of the trial |
To find out the extent of any side-effects of the new drug and whether these side-effects can be tolerated by the patient. The patients' overall survival will be looked at and their quality of life measured using questionnaires. Lastly, the trial aims to predict which patients may benefit from particular treatments in the future, by using blood or tissue samples. A patient can enter the main STOMP trial and choose not to donate blood or tissue to these "sub-studies" that will analyse the blood and tissue. It is anticipated that not all hospitals will be willing and able to participate in the blood collection sub-study and patients will be made aware of this during the consent process. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub-study details are contained within the protocol "Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial", version 1.0, 01/11/10. |
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E.3 | Principal inclusion criteria |
•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.
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E.4 | Principal exclusion criteria |
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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) is defined as the time from randomisation until objective disease progression as defined by RECIST 1.1 or death (by any cause in the absence of progression). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the treatment period is deemed to be 30 days after the last day of treatment since this is the standard reporting window for serious adverse events. The end of the trial is predicated on the survival of the patients but it is anticipated to be approximately 10 months after the randomisation of the final patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 1 |