NCT00512798: Bortezomib plus temozolomide for refractory tumors

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Terminated

NCT00512798 studied bortezomib plus temozolomide in advanced refractory solid tumors and melanoma. The Vanderbilt phase 1/2 design used an initial dose-finding component for refractory solid tumors and a melanoma-focused phase 2 component. The registry records 47 actual participants and a terminated status in its 2012 update. 1 2 3

The biological rationale involved proteasome/NF-κB signaling and possible enhancement of temozolomide activity. That rationale is not itself proof of response or survival improvement. The registry now posts results: in the phase 1 group of 19, it lists 0 complete responses, 4 partial responses, 1 stable disease and 14 progressive disease; in the phase 2 group of 28, it lists 0 complete responses, 1 partial response, 5 stable disease and 22 progressive disease. These are small, uncontrolled groups and do not establish improvement over another treatment. The registry does not support assigning an unverified cause to termination. 1 2 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00512798. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00512798. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. Additional registry-derived listing showing posted-results history — Additional registry-derived listing showing posted-results historyCited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.