Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer
Trial overview
Percentage of participants with overall response rate (ORR) following administration of SB-715992
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Median time to radiographic response after administration of SB-715992
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Median time to CA-125 response after administration of SB-715992
Timeframe: Day 1 of the Treatment Cycle 2 up to post study treatment visit.
Median duration of CR or PR radiographic response after administration of SB-715992
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Median duration of Progression-free survival (PFS) after administration of SB-715992
Timeframe: Day 1 of the Treatment Cycle 2 up to post study treatment visit.
Number of participants with any adverse event (AE) or serious adverse event (SAE) and fatal AE of death.
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Number of participants with vital sign values of Potential Clinical Concern (PCC) at any visit post-Screening
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Number of participants with clinical chemistry laboratory toxicity grades shifts from Baseline toxicity grade at any visit post-Baseline
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Number of participants with hematology laboratory toxicity grades shifts from Baseline toxicity grade at any visit post-Baseline
Timeframe: From date of Randomization until the date of first documented progression, date of death from any cause, withdrawal from treatment due to an unacceptable toxicity or withdrawal of consent, whichever came first, assessed up to 29 months.
Mean plasma concentration of SB-715992
Timeframe: Day 1 of the Treatment Cycle 1 at the following timepoints: immediately following completion of infusion, 2 to 4 hours following completion of infusion and 24 to 36 hours following completion of infusion.
Potential surrogates of clinical response/resistance to SB-715992
Timeframe: Screening
Participation criteria
- Inclusion criteria:
- Must have a screening CA-125 of greater than or equal to 40 U/ml.
- 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 more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- Females who are pregnant or nursing.
- Any unstable, pre-existing major medical condition or history of other cancers.
- Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.