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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00391521 |
This is a Phase I trial. Some specific protocol information is proprietary and is not publicly available at this time. Full information will be provided to trial participants.
Condition | Intervention | Phase |
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Solid Tumors |
Drug: R763 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Multicenter, Open-Label, Dose Escalation Trial of R763 Given Orally to Subjects With Solid Tumours |
Estimated Enrollment: | 108 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Regimen 1
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Drug: R763
Regimen 1 subjects will be dosed on Days 1 and 8 of a 21 day cycle according to the dose escalation scheme
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2: Active Comparator
Regimen II
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Drug: R763
Regimen 2 subjects will be dosed on Days 1, 2 and 3 of a 21 day cycle according to the dose escalation scheme
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Local Medical Information Office | 888-275-7376 |
United States, Massachusetts | |
EMD Serono Med Info | Recruiting |
Rockland, Massachusetts, United States, 02370 | |
Contact: Susan Fischer 781-681-2506 |
Study Director: | Narmyn Rejeb, MD | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany |
Responsible Party: | EMD Serono ( Sue Fischer, Clinical Project Manager ) |
Study ID Numbers: | 26865 |
Study First Received: | October 20, 2006 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00391521 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Oncology. All solid Tumour disease. |