Ignite Creation Date:
2024-05-05 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00700258
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2008-06-13
Brief Title:
Registry For Temsirolimus Sunitinib And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma mRCC Mantle Cell Lymphoma MCL And Gastro-Intestinal Stroma Tumor GIST STAR-TOR
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
STAR-TOR- REGISTRY FOR THE EVALUATION OF THE SAFETY TOLERABILITY AND EFFICACY OF TEMSIROLIMUS TORISEL SUNITINIB SUTENT AND AXITINIB INLYTA FOR THE TREATMENT OF SUBJECTS WITH ADVANCED RENAL CELL CARCINOMA MRCC MANTLE CELL LYMPHOMA MCL AND GASTRO-INTESTINAL STROMA TUMOR GIST
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-TOR
Brief Summary:
The purpose of this registry is to obtain a general view as regards efficacy tolerability and safety issues of the Torisel Sutent andor Inlyta therapies in patients with advanced renal cell carcinoma recurrent refractory mantle cell lymphoma MCL and gastro-intestinal stroma tumors GIST under the conditions of routine use
Detailed Description:
Treatment of the metastatic renal cell carcinoma mRCC has experienced fundamental changes within a very short period of time In the past few years introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC Inlyta is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines
Since August 2009 Torisel is available as another treatment option for patients with mantle cell lymphoma MCL In addition Sutent is used for patients with non-resectable metastatic gastro-intestinal stroma tumors GIST after failure or intolerability of imatinib
The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials Therefore the purpose of this registry is to obtain a general view as regards efficacy tolerability and safety issues of the Torisel Sutent andor Inlyta therapies in patients with advanced renal cell carcinoma recurrent refractory mantle cell lymphoma MCL and gastro-intestinal stroma tumors GIST under the conditions of routine use
Therefore the following information is of particular interest in the course of the investigation
Efficacy best response overall survival progression-free survival
Tolerability of the therapy assessed by the physician
Safety profile overall incidence of adverse events as well as side-effect rate of subjects with mRCC rMCL and GIST under treatment with Torisel Sutent andor Inlyta
Profile comorbidities and characteristics of subjects treated with Torisel Sutent andor Inlyta
The sequence of using the systemic therapies for RCC MCL and GIST
Patient survey on the quality of life of mRCC patients
Since August 2009 Torisel is available as another treatment option for patients with mantle cell lymphoma MCL In addition Sutent is used for patients with non-resectable metastatic gastro-intestinal stroma tumors GIST after failure or intolerability of imatinib
The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials Therefore the purpose of this registry is to obtain a general view as regards efficacy tolerability and safety issues of the Torisel Sutent andor Inlyta therapies in patients with advanced renal cell carcinoma recurrent refractory mantle cell lymphoma MCL and gastro-intestinal stroma tumors GIST under the conditions of routine use
Therefore the following information is of particular interest in the course of the investigation
Efficacy best response overall survival progression-free survival
Tolerability of the therapy assessed by the physician
Safety profile overall incidence of adverse events as well as side-effect rate of subjects with mRCC rMCL and GIST under treatment with Torisel Sutent andor Inlyta
Profile comorbidities and characteristics of subjects treated with Torisel Sutent andor Inlyta
The sequence of using the systemic therapies for RCC MCL and GIST
Patient survey on the quality of life of mRCC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B1771009 | OTHER | Alias Study Number | None |