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NCT01344031 · ClinicalTrials.gov registry record · Phase 1
MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women With Metastatic Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01344031: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01344031 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01344031, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of MK 2206 (Akt inhibitor MK2206) when given with anastrozole, fulvestrant, or anastrozole and fulvestrant in treating postmenopausal women with breast cancer that has spread to other parts of the body. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Akt inhibitor MK2206 together with anastrozole, fulvestrant, or anastrozole and fulvestrant may kill more tumor cells.
Primary Outcome
Data analysis for the study will be descriptive in nature. Demographic and clinical characteristics of the subjects, toxicity by grade, adverse events, serious adverse events and death will be listed and summarized using descriptive statistics for each dose level.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Anastrozole
- DRUG Fulvestrant
- DRUG Akt Inhibitor MK2206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-04-21 |
| Phase | Phase 1 |
What the finished NCT01344031 record still lists
NCT01344031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01344031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01344031 about?
NCT01344031 is a clinical study titled "MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women With Metastatic Breast Cancer". This phase I trial studies the side effects and the best dose of MK 2206 (Akt inhibitor MK2206) when given with anastrozole, fulvestrant, or anastrozole and fulvestrant in treating postmenopausal women with breast cancer that has spread to other parts of the body. Estrogen can cause the growth of br...
What is the current status of trial NCT01344031?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-04-21.
What interventions are being tested in trial NCT01344031?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Anastrozole (DRUG), Fulvestrant (DRUG), Akt Inhibitor MK2206 (DRUG).
Who is sponsoring clinical trial NCT01344031?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01344031's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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