At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
rhuMAb 2C4drug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Age ≥18 years
- ✓ECOG performance status 0 or 1
- ✓Life expectancy ≥12 weeks
- ✓Histologically documented, incurable, locally advanced or metastatic solid malignancy
Key exclusion· 11
- ✕Pleural effusions, ascites, or bone lesions as only manifestation of current cancer
- ✕Symptomatic or untreated brain metastases
- ✕Prior treatment with Herceptin
- ✕Prior cumulative doxorubicin dose >360 mg/m² or equivalent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating rhuMAb 2C4 for Neoplasms. Completed, enrolled 21 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2001
First PostedNov 2001
Primary CompletionAug 2003
TodayJul 2026
First PostedNov 16, 2001
Enrollment StartNov 1, 2001
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 24.6 years ago
Interventions
rhuMAb 2C4drug