Status:
COMPLETED
PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Carcinoma
Sarcoma
Eligibility:
All Genders
21-90 years
Phase:
PHASE1
Brief Summary
This study is the first time that a new experimental drug called \[18F\]-SKI-249380 is being used in people. \[18F\]-SKI-249380 is not a therapeutic drug. \[18F\]-SKI-249380 is a drug that will be use...
Eligibility Criteria
Inclusion
- Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm.
- Histology confirmed by MSKCC Department of Pathology.
- Disease that is either:
- Radiologically-measurable or evaluable as defined by tumor response criteria from an MSKCC-IRB approved clinic research protocol.
- Detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within 6 weeks of study enrollment
- Age between 21-90
- Negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.)
- Not breast-feeding, if applicable.
Exclusion
- Refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect \[18F\]-SKI-249380 metabolism. Notably, as dasatinib metabolism is CYP3A4-dependent, the metabolism of \[18F\]-SKI-249380 may be altered by inhibitors and inducers of cytochrome P450 isoenzyme CYP3A4. The acceptability of medications and other substances used by the patient will be determined by the study investigators.
- Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[18F\]-SKI-249380 injection and blood draws.)
- Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
- Hepatic: from assays obtained \<2 weeks prior to study enrollment
- Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
- AST/ALT \>2.5 x ULN
- Albumin \< 2 g/dl
- GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN.
- Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained \<2 weeks prior to study enrollment
- Acute major illness (e.g., unstable cardiovascular condition, etc.)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01916135
Start Date
July 1 2013
End Date
April 23 2020
Last Update
April 27 2020
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065