Trial · NCT00095628
SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
NCT00095628, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer. Trials, record NCT00095628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
- NCT number
- NCT00095628
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic 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
- Interventions
- ispinesib, laboratory biomarker analysis, pharmacological study
- First posted
- 2004-11-08
- Last updated
- 2017-03-06
- Results first posted
- 2017-03-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses) | Up to 18 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion |
| Secondary | Duration of Objective Response | Up to 18 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion |
| Secondary | Number of Participants With Clinical and Objective Stable Disease | Up to 18 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease. |
| Secondary | Median Overall Survival of SB-715992 | Up to 18 months | Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival. |
| Secondary | Median Time to Progression | Up to 18 months | Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP. |
| Other | 1 Year Overall Survival | 12 months | Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses) | Up to 18 months | 20 eligible patients were analyzed | participants | NUMBER |
| SECONDARY | Duration of Objective Response | Up to 18 months | Data were not collected because 0 participants showed a response. | ||
| SECONDARY | Number of Participants With Clinical and Objective Stable Disease | Up to 18 months | participants | NUMBER | |
| SECONDARY | Median Overall Survival of SB-715992 | Up to 18 months | months | MEDIAN | |
| SECONDARY | Median Time to Progression | Up to 18 months | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | 1 Year Overall Survival | 12 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses) | Treatment (Ispinesib) | 0 | participants | ||
| Number of Participants With Clinical and Objective Stable Disease | Treatment (Ispinesib) | 5 | participants | ||
| Median Overall Survival of SB-715992 | Treatment (Ispinesib) | 3.5 | 95% Confidence Interval 2.8 to 7.8 | months | |
| Median Time to Progression | Treatment (Ispinesib) | 1.4 | 95% Confidence Interval 1.3 to 2.3 | months | |
| 1 Year Overall Survival | Treatment (Ispinesib) | 20 | 95% Confidence Interval 8.3 to 48.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ispinesib) | 21 | |
| Overall Study | COMPLETED | Treatment (Ispinesib) | 20 | |
| Overall Study | NOT COMPLETED | Treatment (Ispinesib) | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Investigations | Treatment (Ispinesib) | 14 | 20 | |
| other | Leukopenia | Investigations | Treatment (Ispinesib) | 15 | 20 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Ispinesib) | 9 | 20 | |
| other | Lymphopenia | Investigations | Treatment (Ispinesib) | 9 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Ispinesib) | 6 | 20 | |
| other | Hyponatremia | Metabolism and nutrition disorders | Treatment (Ispinesib) | 6 | 20 | |
| other | Fatigue | General disorders | Treatment (Ispinesib) | 5 | 20 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Treatment (Ispinesib) | 3 | 20 | |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Treatment (Ispinesib) | 3 | 20 | |
| other | Vomiting | Gastrointestinal disorders | Treatment (Ispinesib) | 3 | 20 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ispinesib) | ||
| Total, other adverse events | Treatment (Ispinesib) | 20 | 20 |
| Total, serious adverse events | Treatment (Ispinesib) | 6 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00095628
GET https://conductscience.org/api/trials/v1/NCT00095628/events?page=2