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NCT02915744 · ClinicalTrials.gov registry record · Phase 3
A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
A Phase 3 study of Breast Cancer and Metastasis, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 178
- Enrollment target
- 20
- Study locations
NCT02915744: Completed Phase 3 study of Breast Cancer and Metastasis, sponsored by Nektar Therapeutics.
NCT02915744 is a Phase 3 study of Breast Cancer and Metastasis that has completed, run by Nektar Therapeutics. The registered enrollment target is 178 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915744, a Phase 3 study of Breast Cancer and Metastasis, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 178 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).
Primary Outcome
To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Eribulin
- DRUG Vinorelbine
- DRUG Ixabepilone
- DRUG NKTR-102
Study Locations (20)
Florida
- Investigator Site - Miami - Miami
- Investigator Site - Plantation - Plantation
- Investigator Site - West Palm Beach - West Palm Beach
California
- Investigator Site - Orange - Orange
- Investigator Site - San Francisco - San Francisco
Texas
- Investigator Site - Fort Worth - Fort Worth
- Investigator Site - Houston - Houston
Arizona
- Investigator Site - Tucson - Tucson
Georgia
- Investigator Site - Athens - Athens
Maryland
- Investigator Site - Baltimore - Baltimore
Massachusetts
- Investigator Site - Boston - Boston
Minnesota
- Investigator Site - Minneapolis - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2016-11 |
| Est. Completion | 2020-07 |
| Phase | Phase 3 |
What the finished NCT02915744 record still lists
NCT02915744 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.
NCT02915744 names 20 study sites across 16 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02915744 about?
NCT02915744 is a clinical study titled "A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine". This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant o...
What is the current status of trial NCT02915744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 178 participants. The study started on 2016-11. Estimated completion is 2020-07.
What conditions does trial NCT02915744 study?
This clinical trial studies the following conditions: Breast Cancer, Metastasis.
What interventions are being tested in trial NCT02915744?
The interventions under investigation include: Gemcitabine (DRUG), Eribulin (DRUG), Vinorelbine (DRUG), Ixabepilone (DRUG), NKTR-102 (DRUG).
Who is sponsoring clinical trial NCT02915744?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02915744 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02915744's enrollment target sits among peer trials
178 410th of 1224 higher than 813 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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