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A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)

Intervention: Imatinib mesylate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Novartis, Study Chair, Affiliation: Novartis

Summary

In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.

Clinical Details

Official title: Open, Randomized, Phase II Study of Glivec in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Plus 10 Year Extension Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Best Tumor Response (Core)

Best Tumor Response (Core + Extension)

Secondary outcome:

Overall Survival (Core)

Overall Survival (Core + Extension)

Duration of Response (Core)

Duration of Response (Core + Extension)

Progression Free Survival (PFS) (Core + Extension)

Time to Treatment Failure (Core)

Time to Treatment Failure (Core + Extension)

Time to Onset of Response (Core)

Time to Onset of Response (Core + Extension)

Time to Progression (Core + Extension)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and non-pregnant women ≥18 years of age with the histopathologically documented

diagnosis of malignant GIST that was unresectable and/or metastatic. Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required

- At least one measurable lesion, as defined by Southwestern Oncology Group (SWOG)

Solid Tumor Response Criteria, which had not been previously embolized or irradiated

- Performance status ≤3 as defined by the Eastern Cooperative Oncology Group (ECOG)

criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: Total bilirubin <1. 5 times upper limit of normal (ULN), aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) <2. 5 x ULN (or <5 x ULN if hepatic metastases were present), creatinine <1. 5 x ULN, absolute neutrophil count (ANC) >1. 5 x 10^9/L, platelet count >100 x 10^9/L Exclusion Criteria:

- Patients with fewer than five years of disease-free survival from any other

(non-GIST) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ

- Patients with known brain metastases

- Evidence of any of the following disorders: Grade III/IV cardiac failure as defined

by the New York Heart Association Criteria, severe concomitant disease, acute or known chronic liver disease (i. e. chronic active hepatitis, cirrhosis) or HIV infection

- Chemotherapy or other investigational therapy within four weeks prior to study entry

(six weeks for nitrosourea or mitomycin-C) and/or radiotherapy to ≥25% of the bone marrow

- Inability to cooperate

- Major surgery within two weeks or exposure to other investigational agents within 28

days of entry into the study Other protocol-defined inclusion / exclusion criteria may have applied.

Locations and Contacts

Novartis Investigative Site, Helsinki FIN-00029, Finland

Dana Farber Cancer Institute Dept of Sarcoma Oncology, Boston, Massachusetts 02115, United States

Oregon Health Sciences University Dept. of Oregon Health Sci., Portland, Oregon 97201, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Novartis Investigative Site, Geelong, Victoria 3220, Australia

Additional Information

Starting date: June 2000
Last updated: August 14, 2014

Page last updated: August 23, 2015

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