EMD 525797 in Colorectal & Ovarian Cancer Patients With Liver Metastases

This study is currently recruiting participants.
Verified January 2013 by Merck KGaA
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00848510
First received: February 19, 2009
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

This study is intended to test an experimental 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 ovarian and colorectal cancer which has spread to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing the Study Drug.


Condition Intervention Phase
Colorectal and Ovarian Cancer Patients With Liver Metastasis
Biological: EMD525797
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, Dose-escalation Study to Investigate the Safety, Tolerability, PD and PK of EMD 525797 Using DCE-MRI as a PK Measure of Response in Colorectal and Ovarian Cancer Patients With Liver Metastases After Failure of Standard Therapy

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: At screening visit ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797

  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: Week 1 : Day 2 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797

  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: Week 1 : Day 5 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797

  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: Week 2 : Day 1 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797

  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: Week 3 : Day 1 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797

  • Dynamic Contrast-Enhanced-MRI (DCE-MRI) scans [ Time Frame: Week 5 : Day 1 ] [ Designated as safety issue: Yes ]
    Assess the safety and tolerability of repeated doses of EMD 525797


Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Tumour markers [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: EMD525797
EMD 525797 250mg; IV; week 1 and week 3; EMD 525797 500mg; IV; week 1 and week 3; EMD 525797 1000mg; IV; week 1 and week 3; EMD 525797 1500mg; IV; week 1 and week 3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed written informed consent;
  2. Male or female subjects, aged at least 18 years;
  3. Subjects with liver metastases (3 to 10 cm diameter) from colorectal and ovarian cancers;
  4. failure of standard cancer therapy;
  5. ECOG performance status of 0 to 1 at study entry and an estimated life expectancy of at least 3 months;
  6. Adequate hematological function, defined by absolute neutrophil count (ANC) ≥ 1.5 x .109 / L, platelet count ≥ 100 x .109 / L, and hemoglobin concentration ≥ 9 g / dL;
  7. As subjects with documented liver metastases are treated in this trial, liver function test values are accepted as followed: up to the upper limit of CTC Grade 2. This includes total bilirubin level ≤3 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤5 x ULN.
  8. Adequate renal function defined by serum creatinine ≤1.5 x ULN or a creatinine clearance of ≥50 mL/min calculated by Cockroft-Gault;
  9. Effective contraception (e.g., double barrier method) for both male and female subjects if the risk of conception exists. These subjects must be willing to avoid pregnancy during the study (screening to EOS) as well as for at least 3 months after the last dosing.

Exclusion Criteria:

  1. Any systemic cancer treatment within 30 days before treatment with EMD 525797;
  2. Thrombolytics or oral or parenteral anticoagulants (except to maintain patency of pre existing, permanent indwelling IV catheters) within 10 days prior to study start and during treatment;
  3. Radiotherapy, chemotherapy, surgery, or any investigational drug in the 30 days before the start of treatment in this study, and/or diagnostic biopsies within 2 weeks before the start of treatment in this study;
  4. Previous treatment with anti integrin therapy or anti angiogenic therapy within the last 6 months;
  5. Confirmed or clinically suspected brain metastases;
  6. Known hypersensitivity reactions to the study medication;
  7. History of allergic reactions to other monoclonal antibody (mAb) therapy;
  8. Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic >100 mmHg);
  9. Current history of chronic daily aspirin therapy (ASS at doses ≤ 150 mg is permitted), bleeding disorders, and/or history of thromboembolic events;
  10. Severe peripheral vascular disease or ulceration;
  11. Unstable angina pectoris, or myocardial infarction within 6 months before start of study treatment, clinical significant abnormal ECG at screening;
  12. In women of childbearing potential, pregnancy (absence to be confirmed by beta human chorionic gonadotropin [β HCG] test, unless a subject has previously undergone hysterectomy or bilateral ovariectomy), or lactation period;
  13. Known alcohol or drug abuse;
  14. Participation in another clinical trial within the past 30 days before start of study treatment;
  15. All other significant diseases which, in the opinion of the PI, might impair the patient's tolerance of study treatment;
  16. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  17. Legal incapacity or limited legal capacity (not applicable only in rare cases);
  18. Known HIV infection and/or active hepatitis B or C virus infections;
  19. Ongoing uncontrolled infections;
  20. Contraindications to MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848510

Contacts
Contact: Isabelle Lemoine +41 22 414 3717

Locations
United Kingdom
Christie Hospital Recruiting
Manchester, United Kingdom
Contact: Prof. Gordon Jayson    +44 (0) 161 446 3606    gordon.jayson@christie.nhs.uk   
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Wolfgang Uhl, Dr, Dipl. Chem., Physician Merck KGaA
Principal Investigator: Prof. Gordon Jayson Christie Hosptial, Cancer Research UK Dept. Medical Oncology
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00848510     History of Changes
Other Study ID Numbers: EMR 62242-003
Study First Received: February 19, 2009
Last Updated: January 15, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Ovarian Neoplasms
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 23, 2014