18 and older, female only, with Ovarian Cancer Stage IIIC or Ovarian Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian CancerPrimary· Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months
The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdraws from the study. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions,
Confirmed CR after 6 cycles (18 weeks) of treatment
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
0
Confirmed CR
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
0
Confirmed PR
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
12
Objective Response (Confirmed CR + Confirmed PR)
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
12
Unconfirmed CR
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
0
Unconfirmed PR
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
4
Stable disease (SD)
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
5
Progressive disease (PD)
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
1
Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian CancerSecondary· Baseline to Cycle 3, Week 3 Day 1; Cycle 6, Week 3 Day 1 (each cycle 21 days) up to end of study, approximately 1 year 10 months postdose
A sum of the diameters for all target lesions will be calculated and reported as the baseline sum of diameters, defined as the last non-missing value before initial administration of study treatment. The baseline sum of diameters will be used as reference for characterization of the objective tumor response. The change from baseline in the sum of longest diameters of target lesions is being reported. Negative values indicate an improvement in tumor reduction.
Cycle 3, Week 3 Day 1
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
-39.0
± 41.73
Cycle 6, Week 3 Day 1
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
-52.4
± 41.56
Minimum post-treatment value
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
-48.3
± 41.65
Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian CancerSecondary· Baseline up to 30 days after last dose, up to 1 year 10 months postdose
Treatment-emergent adverse events (TEAEs) were defined as those events that occur, having been absent before the study, or worsen in severity after the initiation of CS-1008 and/or paclitaxel/docetaxel/carboplatin administration. All adverse events (AEs) were graded (1 to 5) according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, where Grade 1 was mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening or disabling, and Grade 5 death related to AE.
Any TEAE ≥Grade 3
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
22
Any Preferred Term Within Blood and Lymphatic System Disorders
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
20
Anaemia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
6
Febrile neutropenia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
1
Leukopenia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
2
Neutropenia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
18
Pancytopenia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
1
Thrombocytopenia
Group
Value
95% CI
CS-1008 in Combination With Paclitaxel/Carboplatin
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 1 year 10 months postdose..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CS-1008 in Combination With Paclitaxel/Carboplatin
This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01220999 — A Phase I Imaging and Pharmacodynamic Trial of CS-1008 in Patients With Metastatic Colorectal Cancer
· Phase 1
· completed
Other recruiting trials for Ovarian Cancer Stage IIIC
Currently open trials in the same condition.
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· Phase 1
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NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 8 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00945191.