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A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer

Phase 1
18 Years
Not Enrolling
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Liver Metastases, Lung Metastases, Recurrent Breast Cancer, Recurrent Pancreatic Cancer, Stage IV Breast Cancer, Stage IV Pancreatic Cancer

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Trial Information

A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer


I. To explore the ability of iRGD (tumor-homing peptide iRGD) to elicit changes in
metastatic breast cancer vascular permeability as measured by dynamic contrast enhanced

II. To evaluate the pharmacokinetics of iRGD. III. To explore the safety of iRGD.


I. To explore changes in water diffusion status in tumors due to iRGD as measured by
diffusion-weighted (DWI) MRI.

II. To explore the ability of iRGD to elicit changes in primary pancreatic cancer vascular
permeability as measured by dynamic contrast enhanced (DCE) MRI.

III. To explore changes in water diffusion status in primary pancreatic cancer due to iRGD
as measured by DWI-MRI.


Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2.

After completion of study treatment, patients are followed up for 15 days.

Inclusion Criteria:

- Patient must have a histologic diagnosis of breast or pancreatic adenocarcinoma
(expansion cohort) metastatic to the liver or lung

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Women of child-bearing potential must have a negative serum pregnancy test within 7
days of the first DCE-MRI and must have agreed to use an effective contraceptive
method; the effects of iRGD on the developing fetus are unknown; for this reason,
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for six months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately

- Patient must have a measurable lesion at least 2 cm in size amenable to DCE-MRI study
as determined by Radiology

- Computed tomography (CT)/MRI scan must be obtained within 3 weeks prior to study

- Absolute neutrophil count >= 1,500/mcl

- Platelet count >= 100,000/mcl

- Creatinine =< 1.3 mg/dl or a measured creatinine clearance >= 60 cc/min

- Bilirubin =< 1.5 mg/dl

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 2.5
times the upper limit of normal for patients with liver metastases; patients without
liver metastasis should have ALT and AST no greater than 1.5 times the upper limit of

- Patients currently being treated for severe infections or who are recovering from
major surgery or other intercurrent illnesses are ineligible until recovery is deemed
complete by the investigator

- All subjects must have the ability to understand and the willingness to sign a
written informed consent

- Patients with grade 2 or higher toxicity due to previous chemotherapy; all toxicities
should recover to grade 0 or 1 prior to day 1

Exclusion Criteria:

- Patients experiencing an infusion reaction with the day 1 DCE-MRI

- Patients with any grade electrolyte abnormalities that are unable to be corrected by
day 1

- Patients with a history of previous reaction to IV contrast

- Impaired cardiac function including any one of the following:

- Complete left bundle branch block or use of a permanent cardiac pacemaker

- Congenital long QT syndrome

- Presence of ventricular tachyarrhythmias

- Clinically significant resting bradycardia (< 50 beats per minute)

- Corrected Fridericia's QT interval (QTcF) > 450 msec on screening
electrocardiogram (ECG)

- Right bundle branch block + left anterior hemiblock (bifascicular block)

- Presence of atrial fibrillation

- Previous history angina pectoris or acute myocardial infarction (MI) within 6 months

- Congestive heart failure (New York Heart Association functional classification

- Uncontrolled hypertension (mmHg > 140 systolic or > 90 diastolic)

- Brain or leptomeningeal metastases

- Patients with an active, bleeding diathesis or requiring therapeutic anticoagulation

- Patients receiving bevacizumab within 3 months of study entry

- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;
baseline testing for HIV and hepatitis C is not required

- Patients should not have any uncontrolled illness including ongoing or active

- Patients may not be receiving any other investigational agents, or concurrent
biological, chemotherapy, or radiation therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to iRGD

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study

Type of Study:


Study Design:

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

Outcome Measure:

Change in volume transfer coefficient (Ktrans) during DCE-MRI with tumor-homing peptide iRGD compared to a baseline DCE-MRI without tumor-homing peptide iRGD

Outcome Description:

Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.

Outcome Time Frame:

Baseline to 15 days

Safety Issue:


Principal Investigator

Vincent Chung

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Federal Government

Study ID:




Start Date:

December 2013

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Liver Metastases
  • Lung Metastases
  • Recurrent Breast Cancer
  • Recurrent Pancreatic Cancer
  • Stage IV Breast Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Pancreatic Neoplasms
  • Lung Neoplasms
  • Carcinoma, Acinar Cell
  • Liver Neoplasms



City of Hope Medical Center Duarte, California  91010