Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003662

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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®.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003662
  •   2012/04/24
  •   2010/05/28
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01141257  (ClinicalTrials.gov)
  •   Pieris001  (Pieris AG)
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Health Condition or Problem studied

  •   Solid Tumor
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Interventions/Observational Groups

  •   Drug: Angiocal® (PRS-050-PEG40)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
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Primary Outcome

- Dose limiting toxicity; time frame: Throughout the course of the study; Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.

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Secondary Outcome

- 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2010/05/31
  •   26
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Pieris AG
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    • Pieris AG
    • Laurent Audoly, PhD 
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    •   [---]*
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    • Pieris AG
    • Laurent Audoly, PhD 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.