Trial record 6 of 165 for:
"Gastrointestinal Stromal Tumors"
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00135005
First received: August 23, 2005
Last updated: May 9, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumors |
Drug: AMN107, STI571 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST) |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle [ Time Frame: From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days ] [ Designated as safety issue: Yes ]MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle
Secondary Outcome Measures:
- To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST [ Time Frame: From day 1 cycle to the study completion visit ] [ Designated as safety issue: Yes ]
- patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle) [ Time Frame: up to 4 cycles after disease profression on imatinib ] [ Designated as safety issue: No ]cycle = 28 days
| Enrollment: | 59 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AMN107 + STI571 | Drug: AMN107, STI571 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with gastrointestinal stromal tumor (GIST).
- Patients who have had disease progression during imatinib therapy with 800 mg.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
- A history of impaired cardiac function or uncontrolled cardiovascular disease.
- Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
- Currently taking certain medications that could affect an electrocardiogram result.
- Women who are pregnant or breast feeding.
- Patients unwilling or unable to comply with the protocol.
NOTE: Additional inclusion and/ or exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135005
Locations
| United States, Massachusetts | |
| Novartis Investigative Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| France | |
| Novartis Investigative Site | |
| Lyon Cedex, France, 69373 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 13125 | |
| Italy | |
| Novartis Investigative Site | |
| Milano, MI, Italy, 20133 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00135005 History of Changes |
| Other Study ID Numbers: | CAMN107A2103, 2005-000561-18 |
| Study First Received: | August 23, 2005 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
GIST AMN107 Gastrointestinal Stromal Tumors |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013