COMPLETEDResults postedPhase 2

Study Of Ispinesib In Subjects With Breast Cancer

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?

Sponsor

GlaxoSmithKline

Enrollment

50 participants

Sites

13 locations

Start Date

June 2004

Completion

August 2006

Neoplasms, BreastIspinesib

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

2.2 years

total trial span

Rate

pts/month needed

At 13 sites, each site needs to enroll approximately 0.2 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

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.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 2

Study Of Ispinesib In Subjects With Breast Cancer

Sponsor

GlaxoSmithKline

Enrollment

50 participants

Sites

13 locations

Start Date

June 2004

Completion

August 2006

Neoplasms, BreastIspinesib

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

2.2 years

total trial span

Rate

pts/month needed

At 13 sites, each site needs to enroll approximately 0.2 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

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

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Study Of Ispinesib In Subjects With Breast Cancer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Study Of Ispinesib In Subjects With Breast Cancer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (13)