Trial Outcomes & Findings for Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy (NCT NCT01270880)
NCT ID: NCT01270880
Last Updated: 2018-09-18
Results Overview
Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
At 6 months
Results posted on
2018-09-18
Participant Flow
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Overall Study
Never rec'd treatment, but registered.
|
1
|
Baseline Characteristics
Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsOur primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy
|
0.0 proportion with 6+ months PFS
Interval 0.0 to 0.137
|
SECONDARY outcome
Timeframe: From baseline to 12 weeksPercentage change in PSA from baseline.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Percentage Change in PSA
|
78.65 percentage change from baseline PSA
Interval 34.11 to 353.45
|
SECONDARY outcome
Timeframe: Day 1, 8, and 15 of each course and at end of treatmentOverall safety and tolerability of STA-9090 by total number of grade 3 adverse events
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Overall Safety and Tolerability of STA-9090
|
35 events of grade 3+ toxicity
|
SECONDARY outcome
Timeframe: From first dose to death or the date last known aliveOverall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy
|
12.5 months
Interval 1.5 to 17.7
|
SECONDARY outcome
Timeframe: At 6 monthsAssociation of PFS with PSA using Cox PH regression model
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Association of PFS With PSA
|
1.000 Hazard Ratio
Interval 0.999 to 1.001
|
SECONDARY outcome
Timeframe: At baseline, day 1 of course 3, and end of treatmentPopulation: No data was collected for this outcome.
Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 participants at risk
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
4/18 • Number of events 4
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Fatigue
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Investigations, other
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 participants at risk
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
33.3%
6/18 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
27.8%
5/18 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increase
|
33.3%
6/18 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
10/18 • Number of events 10
|
|
General disorders
Fatigue
|
38.9%
7/18 • Number of events 7
|
|
Renal and urinary disorders
Hematuria
|
22.2%
4/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
8/18 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.9%
7/18 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
38.9%
7/18 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
9/18 • Number of events 9
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Weight loss
|
27.8%
5/18 • Number of events 5
|
|
Investigations
White blood cell decreased
|
22.2%
4/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
4/18 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 3
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Pain
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Pain in extremity
|
22.2%
4/18 • Number of events 4
|
|
Investigations
Serum amylase increased
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Infusion related reaction
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
3/18 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
4/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.8%
5/18 • Number of events 5
|
|
Investigations
Investigations - other
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Lipase increased
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
2/18 • Number of events 2
|
Additional Information
Elisabeth I. Heath, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place