Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

CS-1008 will be administered with paclitaxel and carboplatin.

CS-1008 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

CS-1008

Paclitaxel 175 mg/m\^2 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) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Global Clinical Leader

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.

This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.

Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

Phase 2 Study of CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

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.

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.

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.

Daiichi Sankyo

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.

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.

CS-1008 in Combination With Paclitaxel/Carboplatin

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Baseline characteristics were assessed in the Safety Analysis Set.

Contact of Clinical Trial Information

Confirmed CR after 6 cycles (18 weeks) of treatment

Confirmed CR

Confirmed PR

Objective Response (Confirmed CR + Confirmed PR)

Unconfirmed CR

Unconfirmed PR

Stable disease (SD)

Progressive disease (PD)

Inevaluable

Best overall response of SD or better

Best overall tumor response and objective response rate were assessed in the Full Analysis Set.

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

Cycle 3, Week 3 Day 1

Cycle 6, Week 3 Day 1

Minimum post-treatment value

The sum of longest diameters of target lesions was assessed in the Full Analysis Set.

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

Any TEAE ≥Grade 3

Any Preferred Term Within Blood and Lymphatic System Disorders

Anaemia

Febrile neutropenia

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Any Preferred Term Within Gastrointestinal Disorders

Abdominal pain

Ascites

Constipation

Enterocolitis

Gastrooesophageal reflux disease

Small intestinal obstruction

Any Preferred Term Within General Disorders and Administration Site Conditions

Chills

Fatigue

Any Preferred Term Within Infections and Infestations

Abdominal abscess

Urinary tract infection

Wound infection staphylococcal

Any Preferred Term Within Investigations

Prothrombin time prolonged

Any Preferred Term Within Metabolism and Nutrition Disorders

Dehydration

Electrolyte imbalance

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypophosphataemia

Any Preferred Term Within Musculoskeletal and Connective Tissue Disorders

Arthralgia

Back pain

Musculoskeletal pain

Any Preferred Term Within Renal and Urinary Disorders

Renal vein thrombosis

Any Preferred Term Within Vascular Disorders

Venous thrombosis

Treatment-emergent adverse events were assessed in the Safety Analysis Set.

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

Overall Study

Spots Global Cancer Trial Database for Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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