Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST)

NCT00782834 | Terminated Phase 2 Results

• 1 other identifier: CAMN107DUS05T
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study of Nilotinib for patients with advanced GIST that cannot be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are testing the benefit of nilotinib in advanced GIST looking at the length of time disease is controlled as well as the response of the disease to the drug.

Conditions

Gastrointestinal Stromal Tumors

Keywords

GIST; Nilotinib

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival Rate at 6 Months

  Number of participants that demonstrate progression free survival at 6 months

  6 months

• Response Rate

  Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.

  1year

Interventions

Nilotinib DRUG

400 mg orally twice daily until disease progression, intolerability or withdrawal of consent

Also known as: Tasigna

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed GIST
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 millimeters (mm) with conventional techniques or as \>= 10 mm with spiral CT scan.
• Patients may have received prior chemotherapy or radiation therapy. Patients must have recovered from any prior therapy and at least 4 weeks (6 weeks for nitrosoureas or mitomycin C; 2 weeks for limited field palliative radiation) must have elapsed since prior treatment.
• Patients must have received and progressed on imatinib and sunitinib. Except for nilotinib, patients may have received additional tyrosine kinase inhibitors or additional targeted therapies.
• Age \>= 18 years.
• Life expectancy of greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count \>= 1,500/mcL
• platelets \>= 100,000/mcL
• total bilirubin \<= 1.5 times Upper Limits of Normal (ULN)
• AST(SGOT)/ALT(SGPT) \<= 2.5 X ULN OR \<= 5.0 X ULN if considered due to tumor
• Potassium, magnesium normal or corrected to normal limits prior to initiating drug
• Calcium, phosphorus normal or corrected to normal limits prior to initiating drug
• creatinine within normal institutional limits

You may not qualify if:

• Patients may not be receiving any other investigational agents within 4 weeks.
• Prior or concomitant malignancies (with a relapse in the last 5 years or requiring active treatment) other than GIST and with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ
• Impaired cardiac function at baseline, including any one of the following:
• Left Ventricular Ejection Fraction (LVEF)\< 45% or below the institutional Lower Limits of Normal (LLN) range (whichever is higher)
• Complete left bundle branch block
• Use of a ventricular paced cardiac pacemaker
• Congenital long QT syndrome or family history of long QT syndrome
• History of or presence of significant ventricular or atrial tachyarrhythmias
• Clinically significant resting bradycardia (\< 50 beats per minute)
• QTc \> 450 msec on screening ECG (using the QTcF formula). If QTc \> 450 msec and electrolytes are not within normal ranges (electrolytes should be corrected and then the patient rescreened for QTc.
• Right bundle branch block plus left anterior hemiblock, bifascicular block
• Myocardial infarction within 12 months prior to Visit 1
• Other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
• Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes
• Use of therapeutic coumarin derivatives (i.e. warfarin, acenoucumarol, phenprocoumon)

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Limitations and Caveats

The study failed to meet its accrual goals. Study terminated prior to accruing 17 subjects due to futility of meeting endpoint.

Results Point of Contact

• Title: Margaret von Mehren, M.D., Director of Sarcoma Oncology
• Organization: Fox Chase Cancer Center

margaret.vonMehren@fccc.edu

215-728-2814

Study Officials

• Margaret von Mehren, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2009
• Last Updated: April 22, 2013
• Results First Posted: August 29, 2011

Record last verified: 2013-04

Locations

US (1)