Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004067

Trial Description

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Title

Phase I, Open-label Study to Investigate Safety, Tolerability, PK, and PD of EMD 525797 After Single and Repeated Dosing at Different Dose Levels in Subjects With Hormone-resistant Prostate Cancer With Bone Mets and Progressive Disease Following Prior CTX

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is intended to test an experimental new drug called, EMD 525797 (Study Drug).
This drug is not yet approved for sale and has only been tested in a small number of people
to date (prior to this study starting another research study was carried out involving 37
healthy volunteers receiving the Study Drug). Until more is known about this Study Drug, it
can only be used in research studies.

This research study is planned to answer important questions about how the Study Drug is
tolerated and how it may work in patients with prostate cancer with bone metastases.

This is a small study which is expected to include 24 patients, and will be conducted in
approximately 3 hospitals in Germany and 1 hospital in Brussels, Belgium. The study will
last until the last patient has had their last study visit which is expected to be about 18
months in total.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004067
  •   2012/10/31
  •   2009/08/11
  •   no
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Secondary IDs

  •   NCT00958477  (ClinicalTrials.gov)
  •   EMR62242_002  (Merck KGaA)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   Bone Metastases
  •   C61 -  Malignant neoplasm of prostate
  •   C79.5 -  Secondary malignant neoplasm of bone and bone marrow
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Interventions/Observational Groups

  •   Biological: EMD 525797
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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

- The incidence of dose limiting toxicity during the first 6 weeks of treatment; time frame: 6 weeks
- Total number of adverse events and total number of serious adverse events; time frame: 6 weeks

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Secondary Outcome

- PD Serum levels of anti-EMD 525797 antibodies to characterize the immunogenic potential; time frame: Up to week 7
- PD IL8/6; time frame: Up to week 7
- PD C-Reactive; time frame: Up to week 7

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Countries of Recruitment

  •   Belgium
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2008/10/31
  •   26
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Provision of signed written informed consent

2. Age superior or equal to 18 years

3. Subjects with histological or cytologically proven prostate cancer with evidence of
bone metastases on bone scans or CT / MRI after prior chemotherapy with e.g. taxane
or mitoxantrone Patients should have undergone bilateral orchiectomy or should be on
continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist
or antagonist and should have stopped any anti-androgen therapy for at least 4 weeks
before inclusion in the study. Patients should be either on stable (i.e., since at
least 3 months) ongoing therapy with a bisphosphonate or without any bisphosphonate
therapy. Initiation of a bisphosphonate therapy within this time period prior the
study or during the study is not allowed. Total serum testosterone should be less
than 50 ng/dL or 1.7 nmol/L.

4. Evidence of progressive disease, defined by at least two PSA values above the
individual nadir level with an increase of at least 10% each determined at a minimum
interval of 2 weeks before screening examination. Presence of a measurable lesion is
not required for study entry. Nodal (in lymph nodes superior or equal to 2cm) or
visceral progression is sufficient for trial entry independent of PSA.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at study entry
and an estimated life expectancy of at least 3 months.

6. Adequate hematological function, defined by white blood cell count (WBC) greater than
or equal to 3 x 109/L with absolute neutrophil count (ANC) greater than or equal to
1.5 x 109/L, and lymphocyte count greater than or equal to 0.5 x 109/L; platelet
count greater than or equal to 100 x 109/L; and hemoglobin greater than or equal to 9
g/dL.

7. Adequate hepatic function defined by total bilirubin level less than or equal to 1.5
times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) levels less than or equal to 2.5 x ULN; or, for
subjects with documented metastatic disease to the liver, AST and ALT levels less
than or equal to 5 x ULN.

8. Adequate renal function defined by serum creatinine less than 1.5 mg/dL.

9. Effective contraception. If the risk of conception exists, pregnancy has to be
avoided during the study (SCR to EOS) as well as during at least 3 month after last
dosing using an effective contraception method (e.g. double barrier method)

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Exclusion Criteria

1. Any systemic cytotoxic cancer treatment within 4 weeks before treatment with EMD
525797.

2. Acute pathologic fracture, spinal cord progression, hypercalcemia (within 4 weeks
period prior to screening).

3. Radiotherapy to bone lesions, orthopaedic surgery, or any investigational drug in the
30 days before the start of treatment in this study and during treatment period,
and/or biopsies involving bone within 2 weeks before the start of treatment in this
study.

4. Supraphysiologic doses of steroids (defined as superior or equal to 7.5 mg of
prednisone equivalents per day).

5. Previous treatment with anti-integrin therapy.

6. Confirmed or clinically suspected brain metastases.

7. Known hypersensitivity reactions to any of the components of the study medication.

8. History of allergic reactions to other monoclonal antibody (mAb) therapy.

9. Uncontrolled hypertension (systolic greater or equal to 160 mmHg, diastolic greater
than or equal to 100 mmHg).

10. Current history of chronic daily aspirin therapy (ASS at doses inferior or equal to
100 mg is permitted), bleeding disorders and/or history of thromboembolic events
(history of superficial thrombophlebitis is not an exclusion criterion);
thrombolytics or oral or parenteral anticoagulants within 10 days prior to study
start and during treatment period.

11. Severe peripheral vascular disease or ulceration.

12. Unstable angina pectoris, or myocardial infarction within 6 months before start of
study treatment, clinical significant abnormal ECG at screening

13. Known alcohol or drug abuse.

14. Participation in another clinical trial within the past 30 days before start of study
treatment.

15. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.

16. Ongoing uncontrolled infections, including active or chronic hepatitis B or C,
ongoing HIV infection.

17. Legal incapacity or limited legal capacity.

18. All other significant diseases which, in the opinion of the Investigator, might
impair the subject's tolerance of study treatment.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Merck KGaA
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  • start of 1:1-Block address scientific-contact
    • Merck KGaA
    • Wolfgang Uhl, Dr, Dipl. Chem., Physician 
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    • Merck KGaA
    • Wolfgang Uhl, Dr, Dipl. Chem., Physician 
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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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Status

  •   Recruiting complete, follow-up complete
  •   2011/03/01
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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 .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.