AzTrials
AzTrials

CarcinomaPhase 1NCT01916135

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

A Phase 1 study testing [18F]-SKI-249380, PET/CT scan and Blood draws in people with Carcinoma and Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Carcinoma, Sarcoma, Myeloma
What is being tested?
[18F]-SKI-249380, PET/CT scan and Blood draws
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jul 2013to 23 Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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.

Being tested
[18F]-SKI-249380, PET/CT scan, Blood draws
Keywords
[18F]-SKI-249380, PET Imaging, CT Imaging, 12-182
Medical subject headings
Carcinoma, Sarcoma, Neoplasms, Plasma Cell, Lymphoma, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]-SKI-249380Radiation

  • PET/CT scanProcedure or surgery

    PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. This includes an initial 30-minute PET scanning period, performed. At each subsequent time-point, a 30 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A 30-45 minute scanning time-period is typical for clinical PET studies. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point.

  • Blood drawsOther

    Blood will be drawn at the multiple time points for pharmacokinetic \& metabolite analyses of 18F-SKI-249380. We anticipate these time points to be approximately 1, 5, 15, 30, and 90 minutes and 3 hours (optional), post-injection.

Study groups in NCT01916135
Study groupRoleWhat they receive
[18F]-SKI- 249380 and PET/CT scanningExperimentalPatients will receive an injection of up to 7.5 (0.5-7.5) mCi of [18F]-SKI- 249380, followed by serial PET/CT scanning and blood draws, over a period of 3.5 hours, on a single day. PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. Each patient will be offered the opportunity to repeat the 18F-SKI-249380 injection and subsequent set of post-injection PET-CT scans, once, on a separate date. Each patient may or may not be receiving treatment with dasatinib therapy at the time of 18F-SKI-249380 PET, for their first PET study, as well as repeat PET study, at the discretion of their oncologist according to best clinical judgment.
Receives: Radiation: [18F]-SKI-249380; Procedure: PET/CT scan; Other: Blood draws

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetics

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

    Measured: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

Secondary outcomes (3)

  1. metabolism

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

    Measured: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

  2. biodistribution

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

    Measured: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

  3. radiation dosimetry

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

    Measured: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion23 Apr 2020
  4. Study completion23 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01916135
Sponsor's protocol ID
12-182
Status last verified
Apr 2020
First submitted
31 Jul 2013
Last updated
27 Apr 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]-SKI-249380, PET/CT scan and Blood draws in people with Carcinoma and Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pharmacokinetics (time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01916135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in