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A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumor

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Trial Information

A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors

This is a phase I, open-label, dose escalation study with Angiocal® in patients with solid
tumors using a group sequential adaptive treatment assignment. Patients will be allocated to
different dose levels in small cohorts and will receive one single dose application on Day
1, followed by a repeated dosing period. The primary objective of the study is to evaluate
the safety and tolerability of Angiocal® when administered intravenously to patients with
solid tumors. The secondary objectives of the study are the characterization of the
pharmacodynamic response, evaluation of the pharmacokinetic profile of Angiocal®,
observation of tumor response.

Inclusion Criteria:

- Males or females with advanced, recurrent or metastatic cancer, refractory to
standard therapy;

- Age ≥18 years;

- Signed informed consent form and ability to understand the study procedures.

Exclusion Criteria:

- Concomitant anticancer therapy, including radiation;

- Current or previous (within 30 days of first study dosing) treatment with another
investigational drug or participation in another clinical study;

- Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day);

- Chronic daily treatment with corticosteroids, with the exception of inhaled steroids;

- Inadequate bone marrow function;

- Inadequate liver function;

- Inadequate renal function;

- Patients not receiving anticoagulant medication who have an International Normalized
Ratio (INR) >1.5 or an activated partial thromboplastin time (aPTT) >1.5 x ULN within
7 days prior to first study treatment;

- Patients with lymphomas;

- Evidence of spinal cord compression or brain metastases;

- Other malignancy diagnosed within the previous 5 years;

- Pregnant or lactating females.;

- All patients who do not use a highly effective method of birth control;

- Major surgical procedure (including open biopsy) within 28 days prior to the first
study treatment, or anticipation of the need for major surgery during the course of
the study treatment;

- Minor surgical procedures, within 24 hours prior to the first study treatment;

- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of

- Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular

- History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal
perforation, intra-abdominal abscess within 6 months of enrollment;

- Lung carcinoma of squamous cell histology or any histology in close proximity to a
major vessel;

- Serious non-healing wound, peptic ulcer or bone fracture;

- Known hypersensitivity to the study medication or any of its excipients;

- Evidence of any other medical conditions that may interfere with the planned
treatment, affect patient compliance or place the patient at high risk of
treatment-related complications;

- Previous enrollment in this study;

- Known hepatitis B or C or HIV infection;

- Employees of the sponsor or patients who are employees or relatives of the

Type of Study:


Study Design:

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

Outcome Measure:

Dose limiting toxicity

Outcome Description:

Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.

Outcome Time Frame:

Throughout the course of the study

Safety Issue:


Principal Investigator

Laurent Audoly, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Pieris AG


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2010

Completion Date:

September 2011

Related Keywords:

  • Solid Tumor
  • Angiocal®; PRS-050-PEG40; Solid tumor; Phase I
  • Neoplasms