Trial Outcomes & Findings for Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer (NCT NCT00971945)
NCT ID: NCT00971945
Last Updated: 2021-05-25
Results Overview
This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From first dose to end of follow-up period (up to approximately 33 months)
Results posted on
2021-05-25
Participant Flow
Six participants were enrolled and treated.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Progressive Disease
|
3
|
|
Overall Study
Change in treatment policy
|
1
|
|
Overall Study
Other reasons
|
2
|
Baseline Characteristics
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=6 Participants
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).
|
|---|---|
|
Age, Continuous
|
46.0 Years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 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
|
PRIMARY outcome
Timeframe: From first dose to end of follow-up period (up to approximately 33 months)Population: All treated participants
This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
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).
|
|---|---|
|
Number of Participants Experiencing Adverse Events
|
6 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of follow-up period (up to approximately 33 months)Population: All treated participants
This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed: * Enzyme investigations * Hematology investigations * Hepatobiliary investigations * Lipid investigations * Protein and chemistry analyses * Renal and urinary tract investigations * Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity). Only laboratory test abnormalities with a Grade 3 or higher are reported
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
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).
|
|---|---|
|
Number of Participants Experiencing Laboratory Tests Abnormalities
Hematology investigations
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Tests Abnormalities
Lipid analyses
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of follow-up period (up to approximately 33 months)Population: All treated participants
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."
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
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).
|
|---|---|
|
Overall Response Rate (ORR)
|
5 Participants
|
SECONDARY outcome
Timeframe: 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)Population: All treated participants (enrolled in study NCT01023204 and NCT00971945) with PR
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.
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
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).
|
|---|---|
|
Duration of Response (DOR)
|
840 Days
Interval 229.0 to 1156.0
|
Adverse Events
Treatment Arm
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=6 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Femur fracture
|
16.7%
1/6 • From first dose to 14 days following last dose
|
Other adverse events
| Measure |
Treatment Arm
n=6 participants at risk
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).
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Endocrine disorders
Adrenal haemorrage
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Eye disorders
Lacrimation increased
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
Eye disorders
Conjunctival haemorrage
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Eye disorders
Xerophthalmia
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Eye disorders
Dacryostenosis acquired
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
3/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
General disorders
Oedema
|
83.3%
5/6 • From first dose to 14 days following last dose
|
|
General disorders
Fatigue
|
66.7%
4/6 • From first dose to 14 days following last dose
|
|
General disorders
Asthenia
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
General disorders
Pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Immune system disorders
Seasonal allergy
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Nasopharyngitis
|
66.7%
4/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Paronychia
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Pneumonia mycoplasmal
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Infections and infestations
Purulence
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Wound
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Injury, poisoning and procedural complications
Wound complication
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Investigations
Weight increased
|
50.0%
3/6 • From first dose to 14 days following last dose
|
|
Investigations
Weight decreased
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
4/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Nervous system disorders
Hypoaesthesia
|
100.0%
6/6 • From first dose to 14 days following last dose
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Renal and urinary disorders
Calculus ureteric
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Renal and urinary disorders
Hydronephrosis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Renal and urinary disorders
Residual urine
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Reproductive system and breast disorders
Breast inflammation
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
6/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
66.7%
4/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • From first dose to 14 days following last dose
|
|
Vascular disorders
Phlebitis
|
16.7%
1/6 • From first dose to 14 days following last dose
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER