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A Phase I/II Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TKI258 (CHIR-258) in Patients With Locally Advanced or Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Phase I/II Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TKI258 (CHIR-258) in Patients With Locally Advanced or Metastatic Melanoma


Inclusion Criteria:



- Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint
Committee on Cancer [AJCC] stage IIIB, IIIC or IV) that is refractory to standard
therapy or for which no curative standard therapy exists.

- Measurable disease

- Must be eighteen years of age or older

- Must meet baseline laboratory requirements

- ECOG performance status 0 or 1

- Adults of reproductive potential must agree to use effective contraception or be
sterile

Exclusion Criteria:

- Concurrent therapy with any other investigational agent

- Uncontrolled central nervous system metastases

- Impaired cardiac function or clinically significant cardiac disease

- Received

- chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks

- biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks

- an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting
study drug or has not recovered from side effects of such therapy

- Received any hematopoietic colony-stimulating factor (e.g., G-CSF, GM-CSF) ≤ 2 weeks
prior to starting study drug. Erythropoietin is allowed.

- Has undergone major surgery ≤ 2 weeks prior to starting study drug or has not
recovered from side effects of such surgery.

- Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,
diarrhea, vomiting

- Pregnant or breast feeding women

- History of another primary malignancy that is currently clinically significant or
currently requires active intervention.

- Chronic anticoagulation therapy with full strength aspirin, Coumadin, or heparin.

- History of thromboembolic or cerebrovascular events within the last 12 months.

- History of rectal bleeding, bloody vomit, or spitting up blood within the last 3
months.

- Known diagnosis of HIV infection (HIV testing is not mandatory)

- Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin,
St. John's wort and quinidine is prohibited.

- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
study-drug administration or may interfere with the interpretation of study results
and, in the judgment of the investigator, make the patient inappropriate for this
study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose Expansion: Determine the maximum tolerated dose based on dose limiting toxicity of TKI258

Outcome Time Frame:

end of dose escalation

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2105

NCT ID:

NCT00303251

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Melanoma
  • Locally Advanced or Metastatic Melanoma
  • Melanoma

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
James Graham Brown Cancer CenterLouisville, Kentucky  40202
MD Anderson CancerHouston, Texas  77030