PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative



Status:Active, not recruiting
Conditions:Skin Cancer, Cancer, Cancer, Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 90
Updated:6/7/2018
Start Date:July 2013
End Date:July 2019

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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 used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its
injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find
tumors in patients.

This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is
given to people in tiny amounts by an injection into a vein in their arm, and to see where
[18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study
doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380
are better for finding tumors compared to the standard types of scans that doctors use.


Inclusion Criteria:

- 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 Criteria:

- 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.)
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Mark Dunphy, DO
Phone: 212-639-8131
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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