Trials / Completed
CompletedNCT02063958
Safety and Pharmacology of SNX-5422 Plus Everolimus in Subjects With Neuroendocrine Tumors
A Phase 1, Open-label, Dose-escalation Study of SNX 5422 and Everolimus in Subjects With Neuroendocrine Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Esanex Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in combination with everolimus.
Detailed description
Heat shock protein 90 (Hsp90) plays a central role in the maturation and maintenance of numerous proteins, for example HER2 and mutated EGFR, that are critical for tumor cell viability and growth; SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Hsp90 has been found to be expressed in 95% of subjects with pancreatic neuroendocrine tumors. This study will determine the MTD of SNX-5422 when given in combination with everolimus in patients with neuroendocrine tumors.The clinical starting dose of 50 mg/m2 qod for SNX-5422 in combination with daily everolimus is 50% of the SNX-5422 qod mono-therapy MTD. The choice to continue once every other day SNX-5422 dosing is based on the safety and efficacy profiles from prior studies, so that drug holidays are interspersed into weekly dosing. The planned subsequent dose levels are 75% and 100% of the SNX-5422 qod mono-therapy MTD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNX-5422 | Capsule dosed every other day for 21 days out of a 28 day cycle. Dose escalation based on safety not to exceed a dose of 100 mg/m2. Maintenance therapy of SNX-5422 at the MTD will be allowed for all patients not experiencing significant toxicity. |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2017-03-27
- Completion
- 2018-03-20
- First posted
- 2014-02-17
- Last updated
- 2018-07-30
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02063958. Inclusion in this directory is not an endorsement.