E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a sensitive relapse (extensive or limited disease). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041067 |
E.1.2 | Term | Small cell lung cancer |
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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 assess the therapeutic activity of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse. |
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E.2.2 | Secondary objectives of the trial |
To characterize the safety of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse (more than three months off induction chemotherapy). For patients presenting with an objective response, the duration of response will be assessed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
¨ Histologically proven small cell lung cancer ¨ Chemotherapy naïve or sensitive relapse (that is, off first line treatment > 3 months) ¨ Presence of measurable disease, as defined in the RECIST criteria (see chapter on "Response evaluation"). ¨ Extensive disease when chemotherapy naïve ¨ Age > 18 years ¨ WHO PS 0-2 ¨ Life expectancy > 12 weeks ¨ Adequate organ function as defined by the following criteria: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 100 x 109/L - Serum asparatate aminotransferase (AST; serum glutamate-oxalate transferase (SGOT)) and serum aminotransferase (ALT; serum glutamate-pyruvate transferase (SGPT)) ≤ 2.5 x upperlimit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy. - Total serum bilirubin ≤ 1.5 x ULN - Serum albumin ≥ 3.0 g/dL ¨ For women: patient must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; they also must have a negative serum or urine pregnancy test performed within 28 days before registration and must not be lactating. ¨ For men: patient must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period. ¨ Written informed consent must be given according to ICH/GCP, and national/local regulations. |
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E.4 | Principal exclusion criteria |
¨ Brain metastases (according to CT or MRI scan performed not earlier than one week prior to the start of treatment) ¨ Prior chemotherapy, radiation therapy, surgery or investigational agent within 4 weeks prior to study entry except for palliative radiotherapy to non-target lesions. ¨ Prior treatment with sunitinib (SU011248) or other receptor tyrosinekinase inhibitors ¨ Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should be off radiotherapy for at least 1 month and be off treatment with steroids ¨ Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within 6 months prior to starting study treatment ¨ NCI CTCAE grade 3 hemorrhage within 4 weeks before the start of the treatment ¨ Hypertension ( > 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents. ¨ Ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females. ¨ Other severe acute or chronical medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. ¨ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the disease control rate 8 weeks after the start of treatment, i.e. the percent of patients with complete response, partial response, or stable disease at 8 weeks according to the RECIST criteria. Patients lost to follow up prior to 8 weeks are considered to be a treatment failure. |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | Information not present in EudraCT |
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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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |