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

This study has been completed.
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Pieris AG
ClinicalTrials.gov Identifier:
NCT01141257
First received: May 28, 2010
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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®.


Condition Intervention Phase
Solid Tumor
Drug: Angiocal® (PRS-050-PEG40)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pieris AG:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
    Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.


Secondary Outcome Measures:
  • Pharmacokinetic analysis [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Response of target lesions over time [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    ECOG = Eastern Cooperative Oncology Group

  • Clinical laboratory measures [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
    Hematology, biochemistry, coagulation parameters, and urinalysis.

  • Anti-drug antibodies [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
  • Results of 12-lead Electrocardiogram by time point [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Heart rate, blood pressure and body temperature.

  • Physical examination [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
    Any changes in physical examination findings from baseline visit will just be summarized, since the physical examiniations will not result in measurable values.


Enrollment: 26
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Angiocal®
Angiocal®
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141257

Locations
Germany
Breisgau, Baden-Württemberg, Germany
Ruhrgebiet, Nordrhein-Westfalen, Germany
Sponsors and Collaborators
Pieris AG
FGK Clinical Research GmbH
Investigators
Study Director: Laurent Audoly, PhD Pieris AG
  More Information

No publications provided by Pieris AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pieris AG
ClinicalTrials.gov Identifier: NCT01141257     History of Changes
Other Study ID Numbers: Pieris001
Study First Received: May 28, 2010
Last Updated: October 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pieris AG:
Angiocal®; PRS-050-PEG40; Solid tumor; Phase I

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014