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The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively) | From first dose to end of follow-up period (up to approximately 33 months) |
| Number of Participants Experiencing Laboratory Tests Abnormalities | This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed:
Only laboratory test abnormalities with a Grade 3 or higher are reported | From first dose to end of follow-up period (up to approximately 33 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the number (percentage) of participants achieving either a Complete Response (CR) or Partial Response (PR) to therapy. CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of all target lesions (taking as reference the baseline sum LD). Target Lesions were evaluated according to "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer." |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Local Institution |
Six participants were enrolled and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events | This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively) | All treated participants | Posted | Count of Participants | Participants | From first dose to end of follow-up period (up to approximately 33 months) |
|
|
From first dose to 14 days following last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA version 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2005 | Mar 19, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2007 | Mar 19, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| From first dose to end of follow-up period (up to approximately 33 months) |
| Duration of Response (DOR) | DOR is defined as the median time from the first date of Partial Response (assessed as per the "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer") to the first date of Progressive Disease. Participants were evaluated for DOR in 2 separate studies (NCT01023204 and NCT00971945). Results are representative of the cumulative DOR assessed in both studies. | From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months) |
| Hiroshima |
| Hiroshima |
| 731-0293 |
| Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Local Institution | Toshima-ku | Tokyo | 170-8455 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Experiencing Laboratory Tests Abnormalities | This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed:
Only laboratory test abnormalities with a Grade 3 or higher are reported | All treated participants | Posted | Count of Participants | Participants | From first dose to end of follow-up period (up to approximately 33 months) |
|
|
|
| Secondary | Overall Response Rate (ORR) | ORR is defined as the number (percentage) of participants achieving either a Complete Response (CR) or Partial Response (PR) to therapy. CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of all target lesions (taking as reference the baseline sum LD). Target Lesions were evaluated according to "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer." | All treated participants | Posted | Count of Participants | Participants | From first dose to end of follow-up period (up to approximately 33 months) |
|
|
|
| Secondary | Duration of Response (DOR) | DOR is defined as the median time from the first date of Partial Response (assessed as per the "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer") to the first date of Progressive Disease. Participants were evaluated for DOR in 2 separate studies (NCT01023204 and NCT00971945). Results are representative of the cumulative DOR assessed in both studies. | All treated participants (enrolled in study NCT01023204 and NCT00971945) with PR | Posted | Median | Full Range | Days | From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months) |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| Vomiting | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Adrenal haemorrage | Endocrine disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Conjunctival haemorrage | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Residual urine | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Breast inflammation | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |