| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology. |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To compare the time to tumor progression (TTP) associated with SU011248 versus that associated with IFN-a for the first-line treatment of patients with metastatic renal cell carcinoma
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| E.2.2 | Secondary objectives of the trial |
· To compare the objective response rate (ORR) associated with SU011248 versus that associated with IFN-a for the first-line treatment of metastatic renal cell carcinoma
· To compare the overall survival (OS) associated with SU011248 versus that associated with IFN-a for the first-line treatment of patients with metastatic renal cell carcinoma
· To compare the progression-free survival (PFS) associated with SU011248 versus that associated with IFN-a for the first-line treatment of patients with metastatic renal cell carcinoma
· To compare patient reported outcomes between the two arms of the study
· To evaluate the safety and tolerability of SU011248
· To assess the cost effectiveness of SU011248 compared to IFN-a as first-line treatment for metastatic RCC
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology.
2. Evidence of unidimensionally measurable disease (ie, ³1 malignant tumor mass that can be accurately measured in at least 1 dimension ³20 mm with conventional computerized tomography [CT] or magnetic resonance imaging [MRI] scan, or ³10 mm with spiral CT scan [if spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used, e.g., if reconstruction size is 7 mm, lesion size should be ³14 mm]). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
3. Male or female, 18 years of age or older.
4. ECOG performance status 0 or 1.
5. Resolution of all acute toxic effects of prior radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade £1.
6. Adequate organ function as defined by the following criteria:
· Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) NMT 2.5 x central laboratory upper limit of normal (CL-ULN), or AST and ALT NMT 5 x CL-ULN if liver function abnormalities are due to underlying malignancy
· Total serum bilirubin :NMT 1.5 x CL-ULN
· Absolute neutrophil count (ANC) : major /Equal to 1500/mL
· Platelets : major/equal to100,000/mL
· Hemoglobin : major/equal to 9.0 g/dL
· Serum calcium : NMT 12.0 mg/dL
· Serum creatinine: NMT 1.5 x CL-ULN
· Prothrombin time (PT) NMT 1.5 x CL-ULN
· Left ventricular ejection fraction (LVEF) major/equal to lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan
7.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
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| E.4 | Principal exclusion criteria |
1. Renal cell carcinoma without any clear (conventional) cell component.
2. Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC (including immunotherapy, chemotherapy, hormonal, or investigational therapy).
3. Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
4. NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.
5. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
6. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan.
7. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
8. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
9. Ongoing cardiac dysrhythmias of NCI CTCAE grade major/equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
11. Current treatment on another clinical trial.
12. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or 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.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
· Time to tumor progression (TTP), defined as the time from randomization to first documentation of objective tumor progression or to death due to cancer. TTP data will be censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment, are removed from study follow-up prior to documentation of objective tumor progression, or died of non-cancer-related symptoms including death due to an unknown cause in the absence of documented disease progression. Patients lacking an evaluation of tumor response after randomization will have their event times censored at Day 1.
Seco
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | Information not present in EudraCT |
| 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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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
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