Study of Dasatinib in Children with Solid Tumors or Imatinib Resistant Ph+ Leukemia

• Conditions: Refractory solid tumorsPh+ leukemia; MedDRA version: 14.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022945-52-Outside-EU/EEA
• Lead Sponsor: Children’s Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-26
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Greater than 12 months and less than or equal to 21 years of age at the time of study entry
2. Histologic verification of solid tumor malignancy at original diagnosis or relapse, or had imatinib resistant Ph+ ALL, or CML. Subjects with tumors of the central nervous system were not eligible.
Imatinib resistance in Ph+ CML was defined as any of the following:
a. Increasing white blood cell (WBC) or platelet count while on imatinib therapy
b. Lack of any cytogenetic response after an adequate duration of imatinib therapy, as defined by failure to achieve a complete hematological response after 3 months of imatinib therapy OR failure to achieve a partial or complete cytogenetic response (ie, = 35% Ph+) after 6 months of imatinib therapy
c. Appearance of accelerated or blastic features while on imatinib therapy
d. Reappearance of Ph+ clones after an initial complete cytogenetic response to imatinib
e. An increase in Ph+ cells of > 30% in peripheral blood or bone marrow cytogenetics while on imatinib therapy
f. Imatinib intolerance as defined by development of an AE requiring discontinuation of imatinib therapy
3. Solid tumors with measurable or evaluable disease. Leukemia with measurable disease: for subjects with CML, hematologic, cytogenetic, and molecular studies determined measurable disease. For subjects with ALL, bone marrow blast percentage determined measurable disease.
4. Current disease state for which there is no known curative therapy or one proven to prolong survival with an acceptable quality of life
5. Karnofsky score = 50% for subjects > 10 years of age or Lansky score = 50 for subjects = 10 years of age
6. Organ function requirements
a. Adequate bone marrow function
b. Adequate renal function
c. Adequate liver function
d. Adequate cardiac function
e. Adequate pulmonary function
7. Signed subject informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who met any of the following criteria were excluded from the study.
1. Pregnant or breast-feeding.
2. Use of the following concomitant medications during the study:
a. Growth factors that support the number or function of platelets or white cells within 7 days of study entry
b. Another investigational drug
c. Other anticancer agents
d. Enzyme-inducing anticonvulsants
e. Antithrombotic and antiplatelet agents
f. Specific CYP3A4 inhibitors
3. Uncontrolled infection
4. Unable to swallow oral or liquid medication
5. Human immunodeficiency virus-positive subjects whose highly active antiretroviral therapy regimen could interact with dasatinib
6. Unable, in the opinion of the investigator, to comply with the safety monitoring requirements of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified