Drugs / indibulin
indibulin
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01113970 | Apr 2010 → Sep 2012 | breast cancer | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00726687 | Jun 2008 → Sep 2009 | cancer | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00591383 | Jan → Dec 2008 | cancer | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00591890 | Oct 2007 → Jun 2008 | — | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00591292 | Jul 2007 → Feb 2009 | cancer | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00591136 | Apr 2003 → Sep 2008 | cancer | Alaunos Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2009-05-30 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Indibulin Translationaland Dose Scheduling Data at ASCO alaunos.com ↗
Three patients had stable disease for a minimum of 6 cycles with 1 patient ongoing in their 11 th cycle of treatment. |
| 2008-07-23 | Alaunos Therapeutics | Results ZIOPHARM Presents Safety and Preliminary Efficacy Data from Two Phase I Studies of Indibulin at AACR Centennial Conference alaunos.com ↗
Of these, prolonged stable disease of greater than 4 months has been observed in 11 patients, with 3 of these patients reaching eight or more months to date. |
| 2008-03-20 | Alaunos Therapeutics | Results ZIOPHARM Presents Promising Early Data from Phase Ib Study of Indibulin at 6th International Symposium on Targeted Anticancer Therapies alaunos.com ↗
Following a total of 30 cycles of treatment, indibulin has been shown to be very well tolerated, with no drug-related Grade 2 or higher toxicities reported. |
| 2007-10-25 | Alaunos Therapeutics | Results Clinical and Preclinical Data for Oral Indibulin (ZIO-301) Presented at AACR/NCI/EORTC Conference alaunos.com ↗
Data presented in two separate posters, "Indibulin (ZIO-301): An Orally Active Tubulin Polymerization Inhibitor with a Unique Molecular Mechanism of Action" and "Translation of Indibulin (ZIO-301) Preclinical Antiangiogenic and Antimetastatic Activity to the Clinic," highlight indibulin's unique molecular mechanism and the demonstration of early clinical activity in the recently initiated U.S. phase I study in various tumor types. |
| 2007-06-03 | Alaunos Therapeutics | Results ZIO-301 (Indibulin) Interim Phase I Data Presented at ASCO alaunos.com ↗
Thus far, stable disease was achieved in 6 patients including 2 patients with colorectal cancer, 2 with salivary gland tumors, one with non-small cell lung cancer and one with prostate cancer. |
| 2007-04-16 | Alaunos Therapeutics | Results ZIOPHARM Presents Unique Mechanism Data for Indibulin at AACR alaunos.com ↗
These data demonstrate that indibulin has distinct biologic and molecular properties from other tubulin binding agents and strongly suggest a very different toxicity profile, particularly with regard to peripheral neuropathy. |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | indibulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00591890 ↗ |
| Known as | D-24851 | ChEMBL registry synonym — accepted as the source's own label CHEMBL49642 ↗ |
| Known as | Indibulina | ChEMBL registry synonym — accepted as the source's own label CHEMBL49642 ↗ |
| Known as | Indibuline | ChEMBL registry synonym — accepted as the source's own label CHEMBL49642 ↗ |
| Known as | ZIO-301 | ChEMBL registry synonym — accepted as the source's own label CHEMBL49642 ↗ |
| Action | Inhibit | “Indibulin, a synthetic inhibitor of tubulin assembly, has shown promising anticancer activity with a minimal neurotoxicity in preclinical animal studies and in Phase I clinical...” PMID 30120268 ↗ Aug 2018 |
| Modality | Small molecule | — CHEMBL49642 ↗ |
| Route | Oral | “Indibulin given orally once a day for 5 days followed by a 9 day rest” NCT01113970 ↗ |