|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 January 2021 |
|
Main ID: |
NCT00135005 |
|
Date of registration:
|
23/08/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
|
|
Scientific 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) |
|
Date of first enrolment:
|
August 2005 |
|
Target sample size:
|
59 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00135005 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
France
|
Germany
|
Italy
|
United States
| | | | |
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Gastrointestinal Stromal Tumors
|
|
Intervention(s)
|
|
Drug: AMN107, STI571
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST
[Time Frame: From day 1 cycle to the study completion visit]
|
|
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]
|
|
Secondary ID(s)
|
|
2005-000561-18
|
|
CAMN107A2103
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|