Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01372618 · ClinicalTrials.gov registry record · Phase 1
Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01372618 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 9 participants.
The verdict
NCT01372618, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230) in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in reducing the occurrence of invasive breast cancer. Unfortunately, treatment with antiestrogens carries potential serious side effects and toxicities that are intolerable to some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will be at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents mammary development by inhibiting IGF-1 action directly in the mammary gland and also indirectly without causing menopausal symptoms. This study is an expansion of work that we have previously done in women with atypical hyperplasia of the breast, which showed that treatment with pasireotide for 10 days caused a reduction in the cellularity of these precancerous lesions. In our present study, women with DCIS will be treated with pasireotide for 20 days prior to surgical excision. Endpoints will be as follows: 1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis (signs of tumor growth), and stimulate apoptosis (cell death) in surgically excised tissue in comparison to core biopsies from women with estrogen receptor (ER) positive DCIS. Both the core biopsy and surgical excision are standard of care procedures that women with DCIS have regardless of participation in this trial. 2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with pasireotide and evaluate for changes in tumor volume and other tumor related features 3. In our previous study we found that many women experienced a slight elevation in blood sugar with 10 days of treatment with pasireotide. Other work has shown that this effect often resolves with greater duration of treatment. We are therefore expanding the duration of
Interventions
- DRUG SOM 230 / Pasireotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01372618
The ClinicalTrials.gov registry entry for NCT01372618 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SOM 230 / Pasireotide is the first listed.
NCT01372618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01372618 about?
NCT01372618 is a clinical study titled "Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor". This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230) in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in reducing the occurrence ...
What is the current status of trial NCT01372618?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01372618?
The interventions under investigation include: SOM 230 / Pasireotide (DRUG).
Who is sponsoring clinical trial NCT01372618?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.