E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal Cell Carcinoma Stage III,
Renal Cell Carcinoma Stage IV,
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038400 |
E.1.2 | Term | Renal carcinoma stage IV |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10038399 |
E.1.2 | Term | Renal carcinoma stage III |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10050076 |
E.1.2 | Term | Metastatic renal carcinoma |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols, who are tolerating study drug and displaying clinical benefit.
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|
E.2.2 | Secondary objectives of the trial |
To assess long-term adverse events and serious adverse events in
subjects who continue on tivozanib hydrochloride
To provide to tivozanib hydrochloride as a treatment option for subjects
who received sorafenib in Study AV-951-09-902 and were tolerating
sorafenib and displaying clinical benefit at the time of study termination |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit.
a. Subjects who received tivozanib hydrochloride at any time while on
parent protocol AV-951-12-205, regardless of sequence, may enroll if
they tolerated and displayed clinical benefit while receiving tivozanib
hydrochloride.
b. Subjects receiving sorafenib in Study AV-951-09-902 who were
tolerating sorafenib and displaying clinical benefit at the time of study
termination may initiate tivozanib hydrochloride as a treatment option.
2. If female of childbearing potential, documentation of negative pregnancy test prior to enrollment.
3. Ability to give written informed consent
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|
E.4 | Principal exclusion criteria |
1. > 4 weeks since discontinuation of study drug on a previous AVEO
sponsored clinical trial
For subjects initiating tivozanib hydrochloride (ie receiving sorafenib
and demonstrating tolerability and clinical benefit on Study AV-951-09-
902 at the time of study termination), > 4 weeks since last dose of
sorafenib, unless discussed with Sponsor.
2. Pregnant or lactating
3. Sexually active male and pre-menopausal female subjects (and their
partners) unless they agree to use adequate contraceptive measures,
while on study and for 45 days after the last dose of study drug. All
fertile male and female subjects (and their partners) must agree to use a
highly effective method of contraception.
4. Uncontrolled hypertension.
5. Unhealed wounds (including active peptic ulcers)
6. Serious/active infection or infection requiring parenteral antibiotics
7. Life-threatening illness or organ system dysfunction compromising
safety evaluation
8. Psychiatric disorder, altered mental status precluding informed
consent or necessary testing
9. Inability to comply with protocol requirements
Drugs and treatments to be excluded and dietary restrictions during
study participation
The following medications are prohibited:
1. Systemic agents targeting the VEGF pathway except
a) Subjects who received sunitinb, regardless of sequence, in Study AV-
951-12-205
b) Subjects who received sorafenib in Study AV-951-09-902 who were
tolerating study drug and displaying clinical benefit at the time of study
termination
2. Chemotherapy, other signal transduction inhibitors, monoclonal
antibodies, immunotherapy or biological response modifiers (if taken as
part of parent protocol then allowed).
3. Cytochrome P450 (CYP3A4) inducers for the duration of study
treatment
4. Steroid therapy equivalent of prednisone > 10 mg/day
(except for steroid premedications used for paclitaxel administration). |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
allow continued access to tivozanib |
|
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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
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) | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
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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
|
The end of the study is the last study visit of the last subject .The study
will continue until all enrolled subjects have been discontinued from
the study |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
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 | 10 |