E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065143 |
E.1.2 | Term | Malignant solid tumour |
E.1.2 | System Organ Class | 100000004864 |
|
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 objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736 containing treatment arm in a previous AG-013736 trial and who had documented stable or responding disease at the time they discontinued in the trial. Continuing access will be provided to patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial
- Patients who were receiving AG-013736 tablets at the time their previous trial ended
- Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease)
- Patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start.
- Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines |
|
E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the trial:
- Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
All patients will be assessed for safety by monitoring adverse events and laboratory values per standard clinical practice. Response to therapy will not be evaluated. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
All patients will be assessed for safety by monitoring adverse events and laboratory values per standard clinical practice. Response to therapy will not be evaluated. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 |
Continuation study for patients previously receiving AG-013736 in clinical trials. |
|
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 | 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
| 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 | 4 |
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 |
Chile |
China |
Czech Republic |
Hungary |
India |
Japan |
Korea, Republic of |
Philippines |
Russian Federation |
Taiwan |
Ukraine |
United States |
|
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
|
End of Trial in all participating countries is defined as the time at which all patients enrolled in the study have completed treatment on study. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 13 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 24 |