Trial Outcomes & Findings for Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer (NCT NCT00945191)
NCT ID: NCT00945191
Last Updated: 2021-04-08
Results Overview
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, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months
Results posted on
2021-04-08
Participant Flow
A total of 24 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 3 clinic sites in the United States.
Following debulking surgery, participants with suboptimal resection (ie, residual tumor \> 1 cm) and measurable/evaluable tumor by imaging techniques were eligible for participation in this study. Debulking surgery occurred within 6 weeks before enrollment in the study.
Participant milestones
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
Overall Study
Did not achieve a complete response
|
18
|
|
Overall Study
Participant relocated to another state
|
1
|
|
Overall Study
Disease progression
|
3
|
|
Overall Study
Serious adverse event or adverse event
|
1
|
|
Overall Study
Investigator's discretion
|
1
|
Baseline Characteristics
Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer
Baseline characteristics by cohort
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 Participants
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 9.96 • n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 monthsPopulation: Best overall tumor response and objective response rate were assessed in the Full Analysis Set.
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, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR.
Outcome measures
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 Participants
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Confirmed CR after 6 cycles (18 weeks) of treatment
|
0 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Confirmed CR
|
0 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Confirmed PR
|
12 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Objective Response (Confirmed CR + Confirmed PR)
|
12 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Unconfirmed CR
|
0 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Unconfirmed PR
|
4 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Stable disease (SD)
|
5 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Progressive disease (PD)
|
1 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Inevaluable
|
2 Participants
|
|
Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Best overall response of SD or better
|
21 Participants
|
SECONDARY outcome
Timeframe: 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 postdosePopulation: The sum of longest diameters of target lesions was assessed in the Full Analysis Set.
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.
Outcome measures
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 Participants
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
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 Cancer
Cycle 3, Week 3 Day 1
|
-39.0 mm
Standard Deviation 41.73
|
|
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 Cancer
Cycle 6, Week 3 Day 1
|
-52.4 mm
Standard Deviation 41.56
|
|
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 Cancer
Minimum post-treatment value
|
-48.3 mm
Standard Deviation 41.65
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 1 year 10 months postdosePopulation: Treatment-emergent adverse events were assessed in the Safety Analysis Set.
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.
Outcome measures
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 Participants
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
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 Cancer
Arthralgia
|
1 Participants
|
|
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 Cancer
Back pain
|
1 Participants
|
|
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 Cancer
Any TEAE ≥Grade 3
|
22 Participants
|
|
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 Cancer
Any Preferred Term Within Blood and Lymphatic System Disorders
|
20 Participants
|
|
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 Cancer
Anaemia
|
6 Participants
|
|
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 Cancer
Febrile neutropenia
|
1 Participants
|
|
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 Cancer
Leukopenia
|
2 Participants
|
|
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 Cancer
Neutropenia
|
18 Participants
|
|
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 Cancer
Pancytopenia
|
1 Participants
|
|
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 Cancer
Thrombocytopenia
|
7 Participants
|
|
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 Cancer
Any Preferred Term Within Gastrointestinal Disorders
|
6 Participants
|
|
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 Cancer
Abdominal pain
|
1 Participants
|
|
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 Cancer
Ascites
|
2 Participants
|
|
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 Cancer
Constipation
|
1 Participants
|
|
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 Cancer
Enterocolitis
|
1 Participants
|
|
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 Cancer
Gastrooesophageal reflux disease
|
1 Participants
|
|
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 Cancer
Small intestinal obstruction
|
3 Participants
|
|
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 Cancer
Any Preferred Term Within General Disorders and Administration Site Conditions
|
2 Participants
|
|
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 Cancer
Chills
|
1 Participants
|
|
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 Cancer
Fatigue
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Infections and Infestations
|
3 Participants
|
|
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 Cancer
Abdominal abscess
|
1 Participants
|
|
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 Cancer
Urinary tract infection
|
3 Participants
|
|
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 Cancer
Wound infection staphylococcal
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Investigations
|
1 Participants
|
|
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 Cancer
Prothrombin time prolonged
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Metabolism and Nutrition Disorders
|
5 Participants
|
|
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 Cancer
Dehydration
|
2 Participants
|
|
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 Cancer
Electrolyte imbalance
|
1 Participants
|
|
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 Cancer
Hyperglycaemia
|
1 Participants
|
|
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 Cancer
Hypokalaemia
|
2 Participants
|
|
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 Cancer
Hyponatraemia
|
1 Participants
|
|
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 Cancer
Hypophosphataemia
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Musculoskeletal and Connective Tissue Disorders
|
2 Participants
|
|
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 Cancer
Musculoskeletal pain
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Renal and Urinary Disorders
|
1 Participants
|
|
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 Cancer
Renal vein thrombosis
|
1 Participants
|
|
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 Cancer
Any Preferred Term Within Vascular Disorders
|
1 Participants
|
|
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 Cancer
Venous thrombosis
|
1 Participants
|
Adverse Events
CS-1008 in Combination With Paclitaxel/Carboplatin
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 participants at risk
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
3/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Gastrointestinal disorders
Enterocolitis
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Gastrointestinal disorders
Ascites
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
3/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Infections and infestations
Abdominal abscess
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
|
Vascular disorders
Venous thrombosis
|
4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
|
Other adverse events
| Measure |
CS-1008 in Combination With Paclitaxel/Carboplatin
n=24 participants at risk
Participants who received CS-1008 in combination with paclitaxel and carboplatin. CS-1008 was administered as an intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6. Paclitaxel 175 mg/m\^2 was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles. Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) was administered as an IV infusion once every 3 weeks (1 cycle) for 6 cycles.
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Blood and lymphatic system disorders
Anaemia
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12.5%
3/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Blood and lymphatic system disorders
Neutropenia
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8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Blood and lymphatic system disorders
Thrombocytopenia
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8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Abdominal pain
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Ascites
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Constipation
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Diarrhea
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Enterocolitis
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Small intestinal obstruction
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12.5%
3/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Gastrointestinal disorders
Vomiting
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Infections and infestations
Abdominal abscess
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Metabolism and nutrition disorders
Dehydration
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8.3%
2/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Metabolism and nutrition disorders
Electrolyte imbalance
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Metabolism and nutrition disorders
Hypokalaemia
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Vascular disorders
Venous thrombosis
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4.2%
1/24 • Treatment-emergent adverse events (TEAEs) were collected from 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place