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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00027027 |
Purpose
The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: rhuMAb 2C4 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-Label, Multicenter, Dose-Escalation Study of the Safety and Pharmacokinetics of a Recombinant Humanized Antibody to Her2 (rhuMAb 2C4) Administered Every 3 Weeks to Subjects With Advanced Solid Malignancies |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00027027 History of Changes |
| Other Study ID Numbers: | TOC2297g |
| Study First Received: | November 15, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms |