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NCT01234402 · ClinicalTrials.gov registry record · Phase 2
Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT01234402 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 153 participants.
The verdict
NCT01234402, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 participants will be randomized in a 1:1:1 ratio to either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 \[HER2/neu\]-negative) (yes/no) and receipt of prior antiangiogenic therapy. Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.
Interventions
- DRUG Capecitabine
- BIOLOGICAL IMC-18F1
- BIOLOGICAL Ramucirumab DP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01234402
The ClinicalTrials.gov registry entry for NCT01234402 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT01234402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01234402 about?
NCT01234402 is a clinical study titled "Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients". An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in c...
What is the current status of trial NCT01234402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2011-03. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01234402?
The interventions under investigation include: Capecitabine (DRUG), IMC-18F1 (BIOLOGICAL), Ramucirumab DP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01234402?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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