Trial Outcomes & Findings for Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer (NCT NCT00096109)
NCT ID: NCT00096109
Last Updated: 2017-01-16
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2017-01-16
Participant Flow
Cancer center clinic.
Participant milestones
| Measure |
Treatment (Tanespimycin)
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)
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|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Tanespimycin)
n=11 Participants
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
|
Gender
Female
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11 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Tanespimycin)
n=7 Participants
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)
|
|---|---|
|
Response Rate (Complete Response (CR) +Partial Response (PR)
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Tanespimycin)
n=11 Participants
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)
|
|---|---|
|
Progression Free Survival (PFS)
|
2 months
Interval 1.0 to 11.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: No participants were evaluated for her2/neu status.
Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals. PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Tanespimycin)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Tanespimycin)
n=11 participants at risk
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
tanespimycin: Given IV
laboratory biomarker analysis: Correlative studies
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Infections and infestations
Lung Infection
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Alkaline Phosphatase Increased
|
18.2%
2/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Immune system disorders
Anaphylaxis
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Infections and infestations
Pleural Infection
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders - Other, specify
|
18.2%
2/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Investigations
Blood Bilirubin Increased
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
Other adverse events
| Measure |
Treatment (Tanespimycin)
n=11 participants at risk
Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
tanespimycin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
63.6%
7/11 • Number of events 11 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
4/11 • Number of events 6 • 30 days after the last dose of treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
General disorders
Edema Limbs
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Lymphocyte Count Decreased
|
27.3%
3/11 • Number of events 3 • 30 days after the last dose of treatment
|
|
Investigations
Blood Bilirubin Increased
|
18.2%
2/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
27.3%
3/11 • Number of events 4 • 30 days after the last dose of treatment
|
|
Investigations
Aspartate Aminotransferase
|
45.5%
5/11 • Number of events 7 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
4/11 • Number of events 7 • 30 days after the last dose of treatment
|
|
Investigations
White Blood Cell Decreased
|
18.2%
2/11 • Number of events 3 • 30 days after the last dose of treatment
|
|
Cardiac disorders
Ventricular Arrhythmia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 5 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Alkaline Phosphatase Increased
|
27.3%
3/11 • Number of events 5 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Infections and infestations
Infections and Infestations - Other
|
9.1%
1/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
General disorders
Fatigue
|
27.3%
3/11 • Number of events 4 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 4 • 30 days after the last dose of treatment
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
9.1%
1/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
18.2%
2/11 • Number of events 4 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Number of events 5 • 30 days after the last dose of treatment
|
|
Eye disorders
Blurred Vision
|
9.1%
1/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.1%
1/11 • Number of events 3 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 3 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
18.2%
2/11 • Number of events 3 • 30 days after the last dose of treatment
|
|
Skin and subcutaneous tissue disorders
Body Odor
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Renal and urinary disorders
Urinary Tract Pain
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11 • Number of events 2 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • 30 days after the last dose of treatment
|
Additional Information
Elaina Gartner, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: (425) 527-4398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60