At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
ispinesib +2 moredrug
Likely dose
ispinesib (SB-715992) administered intravenouslyAI-extracted
Key inclusion· 8
- ✓Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx, paranasal sinus, nasal cavity, or metastatic/occult primary) that is recurrent or metastatic
- ✓Maximum of one prior chemotherapy regimen for recurrent or metastatic disease; may receive SB-715992 as first-line therapy
- ✓Prior platinum-based chemotherapy with concurrent radiotherapy or induction chemotherapy is allowed
- ✓At least 4 weeks interval between chemotherapy and study enrollment (6 weeks for nitrosoureas or mitomycin C)
Key exclusion· 10
- ✕Non-squamous cell carcinomas of the head and neck or nasopharyngeal cancer
- ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
- ✕Any other investigational agents within 28 days of study entry
- ✕Concurrent anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal except replacement)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of SB-715992 in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
In Brief
A Phase 2 clinical trial evaluating ispinesib, laboratory biomarker analysis, and 1 other intervention for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma and 21 related conditions. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2004
Enrollment StartJan 2005
Primary CompletionJul 2010
TodayJul 2026
First PostedNov 8, 2004
Enrollment StartJan 1, 2005
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 21.7 years ago
Interventions
ispinesibdrug
Given IV
laboratory biomarker analysisother
Correlative studies
pharmacological studyother
Correlative studies