E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Non-Small Cell Lung Cancer (NSCLC) in women. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.1 |
E.1.2 | Level | NOS |
E.1.2 | Classification code | 10029514 |
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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 |
The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Female. 2.Histologically- or cytologically-confirmed diagnosis of NSCLC. (Note: Sputum cytology alone is not acceptable for cell type. Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable). 3.ECOG performance score (PS) of 2. 4.Patients who meet one of the following criteria: •Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or •Stage IV. 5.Age superior or equal to 18 years. 6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC) > or equal to 1,500/µL and platelet count > or equal to 100,000/µL. 7.Adequate renal function demonstrated by creatinine < or equal to 1.5 X the upper limit of normal (ULN). 8.Adequate hepatic function demonstrated by all of the following •Total bilirubin <or equal to 1.5 ULN (CTC grade 1) and •If liver metastases are not present, SGOT and SGPT <or equal to 2.5 x ULN (CTC grade 0 or 1), otherwise SGOT and SGPT must be <or equal to 5 x ULN (CTC grade 0 to 2). 9.Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site’s institutional standards. Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen. Patients must have recovered from therapy for their brain metastases.
10. Patients who have had major surgery must be fully recovered from the surgery. 11.Ability to comply with the visit schedule and assessments required by the protocol. 12. For patients of reproductive potential, commitment to use adequate contraception. 13. Signed approved informed consent, with understanding of study procedures. 14. Agreement to begin study therapy within 8 calendar days after randomization.
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E.4 | Principal exclusion criteria |
None of the following characteristics may be present:
1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. Grade 2 or greater neuropathy. 6. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9). 7. Clinically significant active infection for which active therapy is underway. 8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable. 10. Pregnant women or nursing mothers. 11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Total number of events = deaths required: 400 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |