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Ispinesib

Phase 2

Neoplasms, Breast | Small molecule | Oncology |GSK plc|Last Updated: Feb 26, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Ispinesib · 4 trials · 4 indications

Phase 2 3Phase 1 1
NCT00097409Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian CancerOvarian Cancer
COMPLETED35 Analytics
NCT00089973Study Of Ispinesib In Subjects With Breast CancerNeoplasms, Breast
COMPLETED50 Analytics
NCT00085813Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung CancerNon-Small-Cell Lung Cancer
COMPLETED70 Analytics
PHASE2COMPLETED
Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Study Of Ispinesib In Subjects With Breast Cancer
Neoplasms, BreastUnlock trial analytics
PHASE2COMPLETED
Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer
Non-Small-Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days
once every 21 days
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.

Assessment of Overall Response Rate of tumor.
Plasma levels for SB-715992 and Capecitabine
will be checked at Day 1 for Cycle 1.

Secondary Endpoints

Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days
once every 21 days
Median Time to Response
After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
Duration of Response
After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SB-715992EXPERIMENTALFemales with advanced or metastatic breast cancer were administered Ispinesib

Interventions

NameTypeDescription
IspinesibDRUG -
CapecitabineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * Must have a screening CA-125 of greater than or equal to 40 U/ml. * Must have received only one prior platinum/taxane-based chemotherapy regimen. * Blood tests will be done to check if blood counts are adequate for taking part in the study. Exclusion criteria: * Received mor...

Countries:United StatesBelgiumMalaysiaSingaporeUnited Kingdom
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Frequently asked questions about Ispinesib

What is Ispinesib used for?

Ispinesib is an investigational small molecule being studied for the treatment of solid tumor cancers, including non-small-cell lung cancer, ovarian cancer, and breast cancer. It has been evaluated in clinical trials for these oncology indications.

Who is developing Ispinesib?

Ispinesib is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in clinical development for oncology indications.

What phase is Ispinesib in?

Ispinesib has been studied in Phase 2 clinical trials for non-small-cell lung cancer, breast cancer, and ovarian cancer, and in a Phase 1 trial for solid tumors. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Ispinesib in?

Ispinesib has been evaluated in several completed clinical trials. NCT00085813 studied it in patients with advanced or metastatic non-small-cell lung cancer. NCT00089973 examined it in breast cancer. NCT00097409 tested it in platinum-taxane-refractory or resistant relapsed ovarian cancer. NCT00119171 evaluated it in combination with capecitabine in solid tumors.

Is Ispinesib the same as SB-715992?

Ispinesib is also known by the code name SB-715992. This alternative name may be used in scientific literature and clinical trial registries to refer to the same investigational drug.

How does Ispinesib work?

Ispinesib is a small molecule that targets kinesin spindle protein, an enzyme essential for cell division. By inhibiting this protein, the drug is designed to disrupt mitosis in cancer cells, potentially slowing tumor growth.