EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases
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.
Colorectal and Ovarian Cancer Patients With Liver Metastasis
Biological: EMD 525797
|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|
- Number of Subjects With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to beginning of Week 5 ] [ Designated as safety issue: Yes ]
- Change from Baseline in Vascular and Volumetric Response as Measured by Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Parameters at Beginning of Week 3 [ Time Frame: Baseline, Beginning of Week 3 ] [ Designated as safety issue: No ]The DCE-MRI parameters included tumor K(trans) (volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow), Ve (extracellular, extravascular volume), Vp (blood plasma volume), initial area under the time-concentration curve (IAUC60) (non specific measure of the amount of contrast agent delivered and retained in the tumor), tumor volume and enhancing fraction of the tumor.
- Number of Subjects With Adverse Events (AEs), Serious AEs and Drug Related Reactions [ Time Frame: Up to Week 6 ] [ Designated as safety issue: Yes ]
- Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Response rate is defined as the percentage of subjects achieving complete response (CR) or partial response (PR) according to RECIST Version 1.0 criteria. CR: disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions.
- Number of Subjects With Best Overall Response [ Time Frame: Weeks 6, 11, 17, 23 and thereafter every 12 weeks until 4 weeks after last dose administration ] [ Designated as safety issue: No ]
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score [ Time Frame: Screening, Day 1 of Weeks 1, 3, 5, 7, 11, 17, 23 and thereafter every 12 weeks until 4 weeks after last dose administration ] [ Designated as safety issue: No ]
- Immunogenicity, as characterized by Serum Levels of Anti EMD 525797 Antibodies [ Time Frame: Day 1 of Weeks 1, 3, 5, 6, 7, 11, 17, 23 and end of study (4 weeks after last dose administration) ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: EMD 525797||
Biological: EMD 525797
EMD 525797 will be administered as an intravenous infusion at a dose range of 250 to 1500 milligram as defined in the protocol every 2 weeks. Subjects demonstrating clinical benefit at the beginning of Week 7 may continue treatment at the same dose until disease progression, intolerance to treatment, or withdrawal of consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848510
|Manchester, United Kingdom|
|Study Director:||Prof Sonia Quaratino, MD, PhD, Medical Responsible||Merck KGaA|
|Principal Investigator:||Prof. Gordon Jayson||Christie Hospital, Cancer Research UK Dept. Medical Oncology|