Clinical trial NCT01916135: PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Sarcoma
Myeloma
Lymphoma
Melanoma
Keywords: [18F]-SKI-249380
PET Imaging
CT Imaging
12-182
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: pharmacokinetics
timeFrame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
Secondary outcomes:
measure: metabolism
timeFrame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
measure: biodistribution
timeFrame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
measure: radiation dosimetry
timeFrame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Dunphy, D.O.
role: PRINCIPAL_INVESTIGATOR
References: