CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
ABT-510drug
Likely dose
ABT-510 100 mg subcutaneously twice dailyAI-extracted
Key inclusion· 5
  • ✓Histologically proven squamous cell carcinoma of head and neck not amenable to curative therapy (including radiation or surgery)
  • ✓Tumor must be biopsy accessible
  • ✓Karnofsky performance status ≥70
  • ✓Any number of prior chemotherapy regimens allowed for recurrent or metastatic disease
Key exclusion· 6
  • ✕CNS metastases (brain MRI within 28 days required to exclude)
  • ✕Uncontrolled heart disease including congestive heart failure, angina at rest, MI within 6 months, or uncontrolled hypertension (SBP >160 or DBP >90)
  • ✕Clinically significant cancer-related bleeding (e.g., hemoptysis) or recent bleeding within 4 weeks
  • ✕Serious infection or intercurrent illness requiring immediate therapy

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

Search/NCT00113334
NCT00113334Phase 2Completed
CompareCT.gov

A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

M.D. Anderson Cancer Center·interventional·Posted Jun 8, 2005·Updated Aug 7, 2014

In Brief

A Phase 2 clinical trial evaluating ABT-510 for Head and Neck Cancer. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2005
Enrollment StartApr 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.1 years ago

Interventions

ABT-510drug

100 mg subcutaneously twice daily