A Pilot, Open-label Study of 18F-Fluciclatide PET/CT Imaging in the Evaluation of Anti-angiogenic Therapy in Solid Tumors

Background:

- Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which
preferentially binds with high affinity to alpha(v)beta(3) integrins, which are
up-regulated in and may regulate angiogenesis.

- [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging

- Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of
patients with targeted antiangiogenic drugs

Objectives:

Primary

- To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle
of treatment with targeted anti-angiogenic therapy

- Secondary

- To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F]
Injection in subjects with solid tumors

- To obtain preliminary data on the relationships between [18F]fluciclatide as a
pharmacodynamic marker and standard of care imaging markers of clinical response (e.g.
contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET),
obtained as part of routine clinical follow-up as specified in the referring protocols,
as well as any optional imaging performed

Eligibility:

- Patients greater than or equal to 18 years, with documented malignancy, and solid tumor
greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an
NCI therapy protocol using one of the anti-angiogenic agents described in the full
protocol

- Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL,
prothrombin time (PT) and aPTT less than 2 times normal limits.

- The subject has not received any targeted anti-angiogenic agents within 60 days prior
to pre-treatment (baseline) [18F]fluciclatide administration

Design:

This study is intended to obtain preliminary data on the uptake and retention of
[18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of
the imaging protocol, identification of the most relevant imaging parameters, and allow for
calculation of the number patients required to power a larger study to assess the utility of
PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted
anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center
study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one
pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early
post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed.
The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies
will be evaluated to determine if there is a measureable difference in uptake. Data from the
subject's referring therapy protocol will be reviewed for up to one year. An optional
DCE-MRI scans of the target lesion may also be performed.