E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant Gastrointestinal Stromal Tumor (GIST), Metastatic Breast Cancer, Metastatic Renal Cell Cancer, Pancreatic Neuroendocrine Tumor, Hepatocellular Carcinoma, Prostate Cancer, Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) |
|
E.1.1.1 | Medical condition in easily understood language |
Adv.breast cancer, adv. renal cell cancer, pancreatic neuroendocrine tumor, hepatocellular cancer, prostate cancer, thyroid cancer, non-small cell lung cancer, adv. gastointestinal stromal tumor |
|
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 | 15.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10027655 |
E.1.2 | Term | Miscellaneous and site unspecified neoplasms malignant and unspecified |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 provide access to sunitinib treatment for subjects who have participated in previous “parent” or extension sunitinib protocols and who have the potential as judged by the investigator to derive clinical benefit from sunitinib treatment |
|
E.2.2 | Secondary objectives of the trial |
To assess the long term safety and tolerability of sunitinib.
To assess the duration of clinical benefit for subjects taking sunitinib. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or legal representative) has been informed of all pertinent aspects of the study.
2. Subjects must have participated in a previous Pfizer sponsored parent or extension sunitinib study (as specified below) and, in the opinion of the parent or extension study investigator are thought to have the potential to derive clinical benefit from continued treatment with sunitinib. Eligible parent or extension protocols include: are A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108,
A6181110, A6181111, A6181112, A6181113, A6181120, A6181126, and A6181170.
Other Pfizer sponsored sunitinib studies may be included in the future.
3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Subjects must be male or female, 18 years of age or older.
5. Subject enrollment is within 28 days from the subject’s last dose of SU011248 or 28 days from the subject’s last visit if they were on comparator drug or placebo in the previous SU011248 study.
6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 90-days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
7. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
- Have undergone hysterectomy or bilateral oophorectomy;
- Have medically confirmed ovarian failure or;
- Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological
cause; laboratory confirmation may be indicated. |
|
E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the study:
1. Current treatment in another clinical study.
2. Pregnancy or breastfeeding. Males and females of childbearing potential not using
highly effective contraception or not agreeing to continue highly effective
contraception for at least 90 days after last dose of investigational product; males and females of childbearing potential not using two (2) methods of highly effective
contraception or not agreeing to continue two (2) methods of highly effective
contraception for at least 90 days after last dose of investigational product.
3. 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 subject inappropriate for entry into this study.
4. Left ventricular ejection fraction (LVEF) <50% as assessed by MUGA or ECHO.
5. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The objective of the study is to provide access to sunitinib treatment and assess long term safety, tolerability, and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint. The following will be collected and reported on:
- Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities.
- There will be no formal assessments of efficacy in this study. Duration of clinical
benefit will be summarized to assess the length of time that subjects benefit from
sunitinb (alone or in combination based on the parent protocol).
- For subjects who were taking sunitinib in the parent protocol, duration of clinical
benefit is defined as the length of time subjects remain on sunitinib from the first day of treatment on the parent protocol (or the combination with sunitinib) until the last day of sunitinib treatment in this study. For subjects who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the
length of time subjects are on sunitinib in this study. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
In addition, survival information will be collected in the Case Report Form (eCRF) for A6181111 subjects only during the term of this study as well as after the subjects terminate treatment in this study. This is for the purpose of calculating Overall Survival (OS) for the
A6181111 study. |
|
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 | 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) | 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 | No |
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) | 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.8.2.4 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 |
Australia |
Belgium |
Brazil |
Canada |
Colombia |
France |
Germany |
Hong Kong |
Korea, Republic of |
Mexico |
Philippines |
Spain |
Taiwan |
United Kingdom |
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 collection of the final data point in the study. Because this clinical trial includes a survival endpoint, the last data point is anticipated to be the last survival follow-up (ie date last known alive or of death) prior to the cutoff date for database lock for the final Clinical Study Report. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 14 |