Status:
COMPLETED
Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug
Lead Sponsor:
Pieris Pharmaceuticals GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if Angiocal® (PRS-050-PEG40) is safe and well tolerated when it is injected into the veins of patients with solid tumors. Other purposes of this study are to ...
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01141257
Start Date
May 1 2010
End Date
September 1 2011
Last Update
October 19 2011
Active Locations (2)
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1
Breisgau, Baden-Wurttemberg, Germany
2
Ruhrgebiet, North Rhine-Westphalia, Germany