E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced and/or metastatic renal cell carcinoma |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10068208 |
E.1.2 | Term | Renal neoplasms malignant |
E.1.2 | System Organ Class | 100000005104 |
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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 progression free survival based on local investigator assessment |
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E.2.2 | Secondary objectives of the trial |
•To assess overall response rate and clinical benefit rate based on local investigator assessment
•To assess overall survival
•To assess duration of response in patients with confirmed complete response (CR) or partial response (PR)
•To evaluate safety and tolerability
•To assess quality of life
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patient is ≥ 18 years old at the time of informed consent.
•Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
•Patient must have measurable disease based on RECIST 1.1 criteria
•Patient must have received prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior TKI treatment as monotherapy or in combination with immune checkpoint inhibitor are allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry.
•Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment
•Patient must have a Karnofsky performance status ≥70%.
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E.4 | Principal exclusion criteria |
•Renal cell carcinoma without any clear (conventional) cell component
•Presence of Central Nervous System (CNS) metastases
•Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy.
•Prior treatment with more than 2 lines of therapy (combination treatments are considered 1 line of therapy)
•Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ≤ CTCAE Grade 1, except for liver function test (LFT) levels which must be <Grade 1.
•Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment.
•Administration of any investigational drug within 4 weeks prior to the first dose of study treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early and at the end of study |
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E.5.2 | Secondary end point(s) |
-Overall Response Rate and Clinical Benefit Rate based on local investigator assessment as per RECIST 1.1
-Overall survival
-Duration of Response in the subset of patients with confirmed CR / PR
-Safety and tolerability
-PRO assessed by EQ-5D and FKSI-DRS questionnaires |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ORR, OS, DOR will be evaluated at the same time as the primary endpoint and at the end of study; however, some patients may not have reached these endpoints at the time of the primary endpoint evaluation so the secondary endpoint results at the end of the study should be considered more meaningful. |
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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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 | No |
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 |
Argentina |
Austria |
Canada |
Chile |
Czech Republic |
France |
Germany |
Hungary |
Japan |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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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2 years after the last patient is enrolled or when all patients have died or discontinued from study and are no longer being followed for survival, whichever occurs first |
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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 |