Phase 2
Completed N=50
Study Of Ispinesib In Subjects With Breast Cancer
Source: ClinicalTrials.gov NCT00089973 ↗Enrolled (actual)
50
Serious AEs
46.0%
Results posted
Feb 2018
Primary outcomePrimary: Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib — 8 percentage of participants
Summary
The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:
1. Does breast cancer respond to Ispinesib?
2. What are the side effects of Ispinesib?
3. How much Ispinesib is in the blood at specific times after it is taken?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib |
8 | — |
| SECONDARY Median Time to Response |
8.07 | — |
| SECONDARY Duration of Response |
6.9; 9; 11.7; 19.1 | — |
| SECONDARY Median Time-to-progression After Administration of Inspinesib |
5.86 | — |
| SECONDARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
23; 49; 11 | — |
| SECONDARY Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate |
1; 2; 1; 1; 5; 1 | — |
| SECONDARY Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters |
12; 4; 8; 1; 3; 4 | — |
| SECONDARY Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts |
9; 1; 1; 1; 1; 1 | — |
| SECONDARY Pharmacokinetic (PK) Parameter-Clearance |
— | — |
| SECONDARY PK Parameter-Volume of Distribution |
— | — |
Eligibility Criteria
Inclusion Criteria
- Stage IIIB or Stage IV breast cancer
- Previously received anthracycline and taxane therapy
Exclusion criteria
- Actively receiving anti-cancer therapy agent(s).
Data sourced from ClinicalTrials.gov (NCT00089973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.