Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug
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|ClinicalTrials.gov Identifier: NCT01141257|
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : October 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Angiocal® (PRS-050-PEG40)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Drug: Angiocal® (PRS-050-PEG40)
Single dose of Angiocal® i.v. (intravenous) on Day 1 and further applications of Angiocal® i.v. during a repeated dosing period.
- Dose limiting toxicity [ Time Frame: Throughout the course of the study ]Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.
- Pharmacokinetic analysis [ Time Frame: Throughout the course of the study ]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.
- Development of biomarkers in blood over time [ Time Frame: Throughout the course of the study ]
- Response of target lesions over time [ Time Frame: Throughout the course of the study ]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.
- ECOG performance status [ Time Frame: Throughout the course of the study ]ECOG = Eastern Cooperative Oncology Group
- Clinical laboratory measures [ Time Frame: Throughout the course of the study ]Hematology, biochemistry, coagulation parameters, and urinalysis.
- Anti-drug antibodies [ Time Frame: Throughout the course of the study ]
- Results of 12-lead Electrocardiogram by time point [ Time Frame: Throughout the course of the study ]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.
- Changes of vital signs from the baseline visit [ Time Frame: Throughout the course of the study ]Heart rate, blood pressure and body temperature.
- Physical examination [ Time Frame: Throughout the course of the study ]Any changes in physical examination findings from baseline visit will just be summarized, since the physical examiniations will not result in measurable values.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141257
|Breisgau, Baden-Württemberg, Germany|
|Ruhrgebiet, Nordrhein-Westfalen, Germany|
|Study Director:||Laurent Audoly, PhD||Pieris Pharmaceuticals GmbH|