Trial · NCT00089973
Study Of Ispinesib In Subjects With Breast Cancer
NCT00089973, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-02-26
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ConductScience Library. Study Of Ispinesib In Subjects With Breast Cancer. Trials, record NCT00089973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Ispinesib In Subjects With Breast Cancer
- NCT number
- NCT00089973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Breast
- Interventions
- Ispinesib
- First posted
- 2004-08-20
- Last updated
- 2018-02-26
- Results first posted
- 2018-02-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Median Time to Response | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Time to response was defined as the time between the start of first dose of the study drug until the first documented evidence of partial or complete tumor response (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken as the first time the response was observed. For participants who did not show a tumor response, the time was censored at the time of withdrawal from the study for any reason. It was evaluated using RECIST criteria 1.0. CR for TLs was defined as Disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD. |
| Secondary | Duration of Response | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | For the participants who had a CR or PR, duration of response was defined as the time a CR or PR was first documented, until the first documented sign of disease progression or death. CR for TLs was defined as disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD. The PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, duration of response would be censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner. Due to small number of participants with a response, data was not summarized; however, individual participants data is reported week wise. |
| Secondary | Median Time-to-progression After Administration of Inspinesib | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Time-to-progression was defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The PD as per RECIST criteria 1.0 was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, time-to-progression was censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner. |
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months) | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. |
| Secondary | Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | The vital sign examination included temperature, heart rate, SBP and DBP. Participant data for clinical concern vital parameters; SBP (unit: millimeter of Mercury \[mmHg\]: low concern (LC) and high concern (HC) values as 90 and 180 mmHg; DBP: LC and HC values as 40 and 100 mmHg; heart rate (units: beats per minute \[bpm\]): LC and HC as 50 and 140 bpm; and temperature (units: degree celsius): LC and HC as 36 and 41 degree Celsius; outside the mentioned range were reported. The available data for the participants from Cycle 1 (C1) Day 1 (D1); C2D1, C3D1, C4D1, C5D1, post-treatment and any visit post-screening were reported. |
| Secondary | Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, Red blood cell count, white blood cell count (WBC), lymphocytes, monocytes, granulocytes, neutrophils, ,eosinophils and basophils. The toxicities for the hematology parameters were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. Grade (G) 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The toxicity shift grades for Hemoglobin, Lymphocytes, Neutrophils, platelet count and WBC, were reported. |
| Secondary | Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For clinical chemistry, the parameters assessed were Alanine transaminase (ALT), Aspartate transaminase (AST), Hemoglobin, lymphocytes, neutrophils, platelet count, white blood cell (WBC), albumin, alkaline phosphatase increased, total bilirubin, calcium, creatinine, glucose, potassium and sodium. The toxicities for the clinical chemistry parameters were graded according to the NCI-CTCAE, version 3.0. where; G 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The number of participants with toxicity shift grades for clinical chemistry were reported. |
| Secondary | Pharmacokinetic (PK) Parameter-Clearance | Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months | The assessment of clearance for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. However, the data for analysis of PK parameter was not collected. |
| Secondary | PK Parameter-Volume of Distribution | Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months | The assessment of volume of distribution for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. Additional samples were to be collected in subsequent cycles, only if dose of study drug was adjusted for any reason following Cycle 1. However, the data for analysis of PK parameter was not collected. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | Intent to treat population consisted of all participants (n=50) who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Response | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population | weeks | MEDIAN |
| SECONDARY | Duration of Response | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population. Only those participants available at that particular timepoints were analyzed | Weeks | NUMBER |
| SECONDARY | Median Time-to-progression After Administration of Inspinesib | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population | week | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months) | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X) in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts | After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic (PK) Parameter-Clearance | Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months | The data for the outcome 'PK parameter-clearance' was not collected | ||
| SECONDARY | PK Parameter-Volume of Distribution | Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months | Data for PK parameter 'Volume of distribution' was not collected. |
Source ClinicalTrials.gov
Results by group109
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib | SB-715992 | 8 | percentage of participants | ||
| Median Time to Response | SB-715992 | 8.07 | 95% Confidence Interval 5.4 to 10.7 | weeks | |
| Duration of Response | SB-715992 | Participant 1 | 6.9 | Weeks | |
| Duration of Response | SB-715992 | Participant 2 | 9 | Weeks | |
| Duration of Response | SB-715992 | Participant 3 | 11.7 | Weeks | |
| Duration of Response | SB-715992 | Participant 4 | 19.1 | Weeks | |
| Median Time-to-progression After Administration of Inspinesib | SB-715992 | 5.86 | 95% Confidence Interval 5.57 to 6.14 | week | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SB-715992 | Any SAEs | 23 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SB-715992 | Any AE | 49 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SB-715992 | Any deaths | 11 | Participants |
1 to 10 of 109Source ClinicalTrials.gov
See all 109 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SB-715992 | 50 | |
| Overall Study | COMPLETED | SB-715992 | 0 | |
| Overall Study | NOT COMPLETED | SB-715992 | 50 |
Source ClinicalTrials.gov
Adverse events34
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 | Blood and lymphatic system disorders | SB-715992 | 20 | 50 | |
| other | Vomiting | Gastrointestinal disorders | SB-715992 | 9 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | SB-715992 | 5 | 50 | |
| other | Dizziness | Nervous system disorders | SB-715992 | 4 | 50 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | SB-715992 | 3 | 50 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | SB-715992 | 3 | 50 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | SB-715992 | 5 | 50 | |
| serious | Neutropenia | Blood and lymphatic system disorders | SB-715992 | 2 | 50 | |
| serious | Pericardial effusion | Cardiac disorders | SB-715992 | 1 | 50 | |
| serious | Vomiting | Gastrointestinal disorders | SB-715992 | 3 | 50 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SB-715992 | 11 | 50 |
| Total, other adverse events | SB-715992 | 42 | 50 |
| Total, serious adverse events | SB-715992 | 23 | 50 |
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/NCT00089973
GET https://conductscience.org/api/trials/v1/NCT00089973/results?page=2