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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumors

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2103

NCT ID:

NCT00135005

Start Date:

August 2005

Completion Date:

November 2006

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • GIST
  • AMN107
  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Stromal Tumors

Name

Location

Novartis Investigative SiteBoston, Massachusetts  02115
Novartis Investigative SitePhiladelphia, Pennsylvania  19111-2497