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Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00945191
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : November 18, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer Stage IIIC
Ovarian Cancer Stage IV
Interventions Drug: CS-1008
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 24
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 24
Completed 0
Not Completed 24
Reason Not Completed
Did not achieve a complete response             18
Participant relocated to another state             1
Disease progression             3
Serious adverse event or adverse event             1
Investigator's discretion             1
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description 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 Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Baseline characteristics were assessed in the Safety Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  70.8%
>=65 years
7
  29.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
59.3  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
24
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
1
   4.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   4.2%
White
22
  91.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Best overall tumor response and objective response rate were assessed in the Full Analysis Set.
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR after 6 cycles (18 weeks) of treatment
0
   0.0%
Confirmed CR
0
   0.0%
Confirmed PR
12
  50.0%
Objective Response (Confirmed CR + Confirmed PR)
12
  50.0%
Unconfirmed CR
0
   0.0%
Unconfirmed PR
4
  16.7%
Stable disease (SD)
5
  20.8%
Progressive disease (PD)
1
   4.2%
Inevaluable
2
   8.3%
Best overall response of SD or better
21
  87.5%
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
The sum of longest diameters of target lesions was assessed in the Full Analysis Set.
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mm
Cycle 3, Week 3 Day 1 Number Analyzed 21 participants
-39.0  (41.73)
Cycle 6, Week 3 Day 1 Number Analyzed 19 participants
-52.4  (41.56)
Minimum post-treatment value Number Analyzed 21 participants
-48.3  (41.65)
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline up to 30 days after last dose, up to 1 year 10 months postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-emergent adverse events were assessed in the Safety Analysis Set.
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE ≥Grade 3
22
  91.7%
Any Preferred Term Within Blood and Lymphatic System Disorders
20
  83.3%
Anaemia
6
  25.0%
Febrile neutropenia
1
   4.2%
Leukopenia
2
   8.3%
Neutropenia
18
  75.0%
Pancytopenia
1
   4.2%
Thrombocytopenia
7
  29.2%
Any Preferred Term Within Gastrointestinal Disorders
6
  25.0%
Abdominal pain
1
   4.2%
Ascites
2
   8.3%
Constipation
1
   4.2%
Enterocolitis
1
   4.2%
Gastrooesophageal reflux disease
1
   4.2%
Small intestinal obstruction
3
  12.5%
Any Preferred Term Within General Disorders and Administration Site Conditions
2
   8.3%
Chills
1
   4.2%
Fatigue
1
   4.2%
Any Preferred Term Within Infections and Infestations
3
  12.5%
Abdominal abscess
1
   4.2%
Urinary tract infection
3
  12.5%
Wound infection staphylococcal
1
   4.2%
Any Preferred Term Within Investigations
1
   4.2%
Prothrombin time prolonged
1
   4.2%
Any Preferred Term Within Metabolism and Nutrition Disorders
5
  20.8%
Dehydration
2
   8.3%
Electrolyte imbalance
1
   4.2%
Hyperglycaemia
1
   4.2%
Hypokalaemia
2
   8.3%
Hyponatraemia
1
   4.2%
Hypophosphataemia
1
   4.2%
Any Preferred Term Within Musculoskeletal and Connective Tissue Disorders
2
   8.3%
Arthralgia
1
   4.2%
Back pain
1
   4.2%
Musculoskeletal pain
1
   4.2%
Any Preferred Term Within Renal and Urinary Disorders
1
   4.2%
Renal vein thrombosis
1
   4.2%
Any Preferred Term Within Vascular Disorders
1
   4.2%
Venous thrombosis
1
   4.2%
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.
Adverse Event Reporting Description 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.
 
Arm/Group Title CS-1008 in Combination With Paclitaxel/Carboplatin
Hide Arm/Group Description 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.
All-Cause Mortality
CS-1008 in Combination With Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   0/24 (0.00%) 
Hide Serious Adverse Events
CS-1008 in Combination With Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   9/24 (37.50%) 
Blood and lymphatic system disorders   
Anaemia  1  3/24 (12.50%) 
Neutropenia  1  2/24 (8.33%) 
Thrombocytopenia  1  2/24 (8.33%) 
Gastrointestinal disorders   
Enterocolitis  1  1/24 (4.17%) 
Ascites  1  1/24 (4.17%) 
Constipation  1  1/24 (4.17%) 
Small intestinal obstruction  1  3/24 (12.50%) 
Infections and infestations   
Abdominal abscess  1  1/24 (4.17%) 
Metabolism and nutrition disorders   
Dehydration  1  2/24 (8.33%) 
Electrolyte imbalance  1  1/24 (4.17%) 
Hypokalaemia  1  1/24 (4.17%) 
Vascular disorders   
Venous thrombosis  1  1/24 (4.17%) 
1
Term from vocabulary, MedDRA (13.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
CS-1008 in Combination With Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   11/24 (45.83%) 
Blood and lymphatic system disorders   
Anaemia  1  3/24 (12.50%) 
Neutropenia  1  2/24 (8.33%) 
Thrombocytopenia  1  2/24 (8.33%) 
Gastrointestinal disorders   
Abdominal pain  1  1/24 (4.17%) 
Ascites  1  1/24 (4.17%) 
Constipation  1  1/24 (4.17%) 
Diarrhea  1  1/24 (4.17%) 
Enterocolitis  1  1/24 (4.17%) 
Small intestinal obstruction  1  3/24 (12.50%) 
Vomiting  1  1/24 (4.17%) 
Infections and infestations   
Abdominal abscess  1  1/24 (4.17%) 
Metabolism and nutrition disorders   
Dehydration  1  2/24 (8.33%) 
Electrolyte imbalance  1  1/24 (4.17%) 
Hypokalaemia  1  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/24 (4.17%) 
Vascular disorders   
Venous thrombosis  1  1/24 (4.17%) 
1
Term from vocabulary, MedDRA (13.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact of Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00945191    
Other Study ID Numbers: CS1008-A-U205
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: October 27, 2020
Results First Posted: November 18, 2020
Last Update Posted: April 8, 2021