Drugs / Colestipol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COLESTID | — | 1977-04-04 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02263547 | Mar 2015 → Jun 2016 | — | Derrick Scott Robertson | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02400476 | Feb 2015 → Apr 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01422915 | May 2011 → Mar 2012 | erythropoietic protoporphyria | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00000512 | Jan 1984 → Aug 1989 | coronary atherosclerosis, myocardial ischemia | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00000599 | Jun 1980 → Nov 1994 | arterial occlusion, carotid artery disorder, coronary atherosclerosis, intracranial arteriosclerosis +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT00203476 Comparator | May 2005 → Jan 2008 | hyperlipidemia, hyperlipoproteinemia | Tuscaloosa Research & Education Advancement Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-04-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
The presentation entitled, “Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2-positive early stage breast cancer: the CONTROL trial,” was presented as a poster presentation. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2017-04-04 | Puma Biotechnology, Inc. | Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Colestipol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02263547 ↗ |
| Route | Oral | “orally administered colestipol” NCT01422915 ↗ |