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NCT00103194 · ClinicalTrials.gov registry record · Phase 2
Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer
A Phase 2 study of Recurrent Prostate Cancer and Stage I Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT00103194: Completed Phase 2 study of Recurrent Prostate Cancer and Stage I Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT00103194 is a Phase 2 study of Recurrent Prostate Cancer and Stage I Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 49 participants, below the 136-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103194, a Phase 2 study of Recurrent Prostate Cancer and Stage I Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.
Primary Outcome
PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period. CR: In patients treated with prior radical prostatectomy, a PSA \< 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA \< 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response. PR:
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG lapatinib ditosylate
Study Locations (1)
Pennsylvania
- ECOG-ACRIN Cancer Research Group - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT00103194 record still lists
NCT00103194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 136-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (64% lower).
The record links to 5 conditions, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT00103194 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00103194 about?
NCT00103194 is a clinical study titled "Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer". This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by...
What is the current status of trial NCT00103194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-09. Estimated completion is 2013-06.
What conditions does trial NCT00103194 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage III Prostate Cancer, Stage IIB Prostate Cancer, Stage IIA Prostate Cancer.
What interventions are being tested in trial NCT00103194?
The interventions under investigation include: laboratory biomarker analysis (OTHER), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00103194?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00103194 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00103194's enrollment target sits among peer trials
49 11th of 21 higher than 11 of 21 other Recurrent Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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