CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
ispinesib +1 moredrug
Likely dose
ispinesib given intravenously (specific dose not stated in eligibility or arms)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed advanced or metastatic colorectal cancer
  • ✓Measurable disease (≥20 mm by conventional techniques or ≥10 mm by spiral CT)
  • ✓Prior therapy with 5-FU, CPT-11, and oxaliplatin required
  • ✓At least one prior chemotherapy regimen for advanced disease
Key exclusion· 9
  • ✕Brain metastases
  • ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to entry
  • ✕Any other investigational agents within 28 days of study entry
  • ✕Concurrent anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal)

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

Search/NCT00103311
NCT00103311Phase 2Completed
CompareCT.gov

A Randomized Phase II Non-Comparative Study of SB-715992 Given Weekly or Every Three Weeks in Advanced or Metastatic Colorectal Cancer

National Cancer Institute (NCI)·interventional·Posted Feb 8, 2005·Updated Mar 2, 2015

In Brief

A Phase 2 clinical trial evaluating ispinesib and laboratory biomarker analysis for Recurrent Colon Cancer and 11 related conditions. Completed, enrolled 64 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying how well SB-715992 works in treating patients with advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2005
Enrollment StartJan 1, 2005
Primary CompletionJan 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 21.4 years ago

Interventions

ispinesibdrug

Given IV

laboratory biomarker analysisother

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