- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141257
Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug
October 18, 2011 updated by: Pieris Pharmaceuticals GmbH
A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors
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 investigate how the body of the patients reacts to Angiocal®, how the blood level of Angiocal® develops after injection and how the tumor responds to the injection of Angiocal®.
Study Overview
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 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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baden-Württemberg
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Breisgau, Baden-Württemberg, Germany
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Nordrhein-Westfalen
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Ruhrgebiet, Nordrhein-Westfalen, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Angiocal®
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Single dose of Angiocal® i.v.
(intravenous) on Day 1 and further applications of Angiocal® i.v.
during a repeated dosing period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity
Time Frame: Throughout the course of the study
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Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.
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Throughout the course of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic analysis
Time Frame: Throughout the course of the study
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AUC_0- τ; AUC_0-tlast; AUC_0-∞; C_max; T_max; t_½; CL; V_z; V_ss; RA_AUC; RA_Cmax; RL; dose normalized values (norm) for AUC_0-τ and C_max will be determined by dividing the original toxicokinetic parameter by the dose level.
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Throughout the course of the study
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Development of biomarkers in blood over time
Time Frame: Throughout the course of the study
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Throughout the course of the study
|
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Response of target lesions over time
Time Frame: Throughout the course of the study
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The objective tumor response for target lesions will be presented over time, employing the categories 'complete response', 'partial response, 'progressive disease´ and 'stable disease' and absolute changes.
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Throughout the course of the study
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ECOG performance status
Time Frame: Throughout the course of the study
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ECOG = Eastern Cooperative Oncology Group
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Throughout the course of the study
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Clinical laboratory measures
Time Frame: Throughout the course of the study
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Hematology, biochemistry, coagulation parameters, and urinalysis.
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Throughout the course of the study
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Anti-drug antibodies
Time Frame: Throughout the course of the study
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Throughout the course of the study
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Results of 12-lead Electrocardiogram by time point
Time Frame: Throughout the course of the study
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Changes from the baseline visit will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Changes from the baseline visit in QTc between >30 and <60 ms and >60 ms will be listed and summarized separately.
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Throughout the course of the study
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Changes of vital signs from the baseline visit
Time Frame: Throughout the course of the study
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Heart rate, blood pressure and body temperature.
|
Throughout the course of the study
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Physical examination
Time Frame: Throughout the course of the study
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Any changes in physical examination findings from baseline visit will just be summarized, since the physical examiniations will not result in measurable values.
|
Throughout the course of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Laurent Audoly, PhD, Pieris Pharmaceuticals GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
May 28, 2010
First Submitted That Met QC Criteria
June 9, 2010
First Posted (Estimate)
June 10, 2010
Study Record Updates
Last Update Posted (Estimate)
October 19, 2011
Last Update Submitted That Met QC Criteria
October 18, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pieris001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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