CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Bortezomibdrug
Likely dose
Bortezomib 1.3 mg/m² IV twice-weekly on days 1, 4, 8, and 11 of each 21-day cycleAI-extracted
Key inclusion· 8
  • Histologically confirmed papillary or follicular thyroid cancer (including hurthle cell, insular, columnar cell, tall cell variants)
  • Metastatic disease present
  • At least 1 measurable lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • Unresponsive to prior radioiodine therapy
Key exclusion· 9
  • No prior radiotherapy to the only or measured tumor lesion
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00104871
NCT00104871Phase 2Completed

A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma

National Cancer Institute (NCI)·interventional·Posted Mar 4, 2005·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating Bortezomib for Insular Thyroid Cancer and 5 related conditions. Completed, enrolled 24 participants across 9 sites.

Detailed Summary

This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Study Details

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 4, 2005
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2010
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 21.3 years ago

Interventions

Bortezomibdrug

Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).