Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01141257
• Date of registration: 28/05/2010
• Primary sponsor: Pieris AG
• Public title: Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug
• Scientific title: A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors
• Date of first enrolment: May 2010
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01141257
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Laurent Audoly, PhD
• Affiliation: Pieris AG

Key inclusion & exclusion criteria

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
bleeding;

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

- 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
investigator.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Solid Tumor

Intervention(s)

Drug: Angiocal® (PRS-050-PEG40)

Primary Outcome(s)

Dose limiting toxicity [Time Frame: Throughout the course of the study]

Secondary Outcome(s)

Anti-drug antibodies [Time Frame: Throughout the course of the study]

Changes of vital signs from the baseline visit [Time Frame: Throughout the course of the study]

Clinical laboratory measures [Time Frame: Throughout the course of the study]

Development of biomarkers in blood over time [Time Frame: Throughout the course of the study]

ECOG performance status [Time Frame: Throughout the course of the study]

Pharmacokinetic analysis [Time Frame: Throughout the course of the study]

Physical examination [Time Frame: Throughout the course of the study]

Response of target lesions over time [Time Frame: Throughout the course of the study]

Results of 12-lead Electrocardiogram by time point [Time Frame: Throughout the course of the study]

Secondary ID(s)

Pieris001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FGK Clinical Research GmbH