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A Pilot, Open-Label, Proof-of-Concept Study of the Use of [18F]Fluciclatide PET/CT Imaging in the Evaluation of Anti-Angiogenic Therapy in Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Lung Cancer, Cervical Cancer, Renal Cell Carcinoma, Uterine Cancer

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Trial Information

A Pilot, Open-Label, Proof-of-Concept Study of the Use 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 150,000 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.

Inclusion Criteria


- INCLUSION CRITERIA:

- Adult subjects (greater than or equal to18 years old), with documented malignancy,
with at least one solid tumor greater than or equal to 1 cm in diameter (not within
the liver), who are scheduled to enroll in an NCI therapy protocol using one of the
anti-angiogenic therapy agents (Vandetanib, Cediranib or Bevacizumab)

- The subject has a platelet count of 150,000 x 10(6)/L, hemoglobin value of greater
than 9 g/dL, PT and an aPTT less than 2 times normal limits.

- The subject has a clinically acceptable medical history, physical examination and
vital signs findings during the screening period (from less than 4 weeks before
administration of Fluciclatide (18F) Injection); i.e. Eastern Cooperative Oncology
Group (ECOG) performance score of 0 to 2.

- The subject has had no open surgical wounds in close proximity to the target
lesion(s) within 10 days prior to study entry.

- The subject has not had a biopsy of the target lesion within 7 days of PET/CT
imaging.

- The subject has not had radiation therapy to the region of the target lesion.

- Enrolling in the following NCI anti-angiogenic therapy protocols:

08-C-0020

09-C-0192

07-C-0058

09-C-0019

EXCLUSION CRITERIA:

- The subject is pregnant or lactating.

- The subject is being treated with doses of heparin or warfarin resulting in elevation
of PT or aPTT greater than 2 times normal.

- The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib,
sunitinib) within 60 days prior to pre-treatment (baseline) [18F]fluciclatide PET
imaging. This stipulation does not apply after the baseline [18F]fluciclatide PET
imaging.

- The subject has received another investigational medicinal product (IMP) within 24
hours before or is scheduled to receive another IMP within 24 hours after
Fluciclatide (18F) Injection.

- The subject has any contraindication to any of the study procedures, products used or
its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).

- The subject is unable to lie still for 75 minutes.

- The subject is known to have a history of hyper- or hypo-coagulation syndromes
resulting in prolongation of bleeding parameters. Such coagulopathies include but are
not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency,
Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.

- The subject has undergone a surgical procedure to the target lesion within 28 days
prior to baseline [18F]fluciclatide administration OR is scheduled to undergo a
surgical procedure between the baseline and post 1-cycle [18F]fluciclatide PET/CT.

- The subject has only bone metastasis

ADDITIONAL INCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:

-Serum creatinine within 2 weeks prior to MRI less than or equal to 1.8mg/dl and estimated
glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).

ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:

- The subject has known allergy to gadolinium

- The subject has contraindications to MRI:

- Subjects must weigh less than 136 kg (weight limit for scanner table).

- Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or
other implanted electronic devices or metal not compatible with MRI.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

100173

NCT ID:

NCT01176500

Start Date:

July 2010

Completion Date:

November 2011

Related Keywords:

  • Colon Cancer
  • Lung Cancer
  • Cervical Cancer
  • Renal Cell Carcinoma
  • Uterine Cancer
  • PET Imaging
  • (18F)Fluciclatide
  • Anti-Angiogenic Therapies
  • Solid Tumors
  • Carcinoma
  • Colonic Neoplasms
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
  • Lung Neoplasms
  • Uterine Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892