Trial Outcomes & Findings for Ixabepilone in Treating Patients With Metastatic Prostate Cancer (NCT NCT00087139)
NCT ID: NCT00087139
Last Updated: 2014-05-09
Results Overview
PSA response is defined as a decline from baseline value by \>=50%, or normalization of PSA (PSA \< 0.2 ng/lm), confirmed by a second measurement \>= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry
Results posted on
2014-05-09
Participant Flow
The study was activated on September 16, 2004 and terminated on February 4, 2009 after reaching its accrual goal. A total of 124 patients were recruited from ECOG member institutions.
Participant milestones
| Measure |
Ixabepilone - no Prior Chemo
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
49
|
36
|
|
Overall Study
Treated
|
39
|
48
|
36
|
|
Overall Study
Eligible and Treated
|
35
|
42
|
32
|
|
Overall Study
Patients for the Analysis of PSA Respons
|
30
|
34
|
22
|
|
Overall Study
Patients With Measurable Disease
|
22
|
25
|
24
|
|
Overall Study
Patients With PSA Response
|
10
|
8
|
4
|
|
Overall Study
Patients w/ Measurable Disease Response
|
5
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
49
|
36
|
Reasons for withdrawal
| Measure |
Ixabepilone - no Prior Chemo
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
17
|
13
|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Disease progression
|
9
|
19
|
12
|
|
Overall Study
Ineligible
|
4
|
7
|
4
|
|
Overall Study
Symptomatic deterioration
|
1
|
1
|
3
|
|
Overall Study
Use of coumadin
|
1
|
0
|
0
|
|
Overall Study
Response achieved
|
0
|
1
|
0
|
|
Overall Study
Extradural disease
|
0
|
0
|
1
|
Baseline Characteristics
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone - no Prior Chemo
n=35 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
n=42 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
n=32 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
69 years
n=7 Participants
|
67.5 years
n=5 Participants
|
70 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entryPopulation: If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response rate was only calculated among the first cohort of patients, not including the additional patients with measurable disease.
PSA response is defined as a decline from baseline value by \>=50%, or normalization of PSA (PSA \< 0.2 ng/lm), confirmed by a second measurement \>= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.
Outcome measures
| Measure |
Ixabepilone - no Prior Chemo
n=30 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
n=34 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
n=22 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Proportion of Patients With PSA Response
|
0.33 Proportion of participants
Interval 0.19 to 0.5
|
0.24 Proportion of participants
Interval 0.12 to 0.38
|
0.18 Proportion of participants
Interval 0.06 to 0.37
|
SECONDARY outcome
Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entryPopulation: Only patients with measurable disease were included in this analysis.
Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Outcome measures
| Measure |
Ixabepilone - no Prior Chemo
n=22 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
n=25 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
n=24 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Proportion of Patients With Measurable Disease Response (Best Overall Response)
|
0.23 proportion of participants
Interval 0.09 to 0.42
|
0.08 proportion of participants
Interval 0.01 to 0.23
|
0 proportion of participants
Interval 0.0 to 0.12
|
SECONDARY outcome
Timeframe: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entryPopulation: If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response related analysis was only done among the first cohort of patients, not including the additional patients with measurable disease.
Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.
Outcome measures
| Measure |
Ixabepilone - no Prior Chemo
n=10 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
n=8 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
n=4 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Duration of PSA Response
|
6.0 Months
Interval 1.8 to 8.0
|
7.6 Months
Interval 4.1 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for the assessment.
|
NA Months
The median and 95% confidence interval were not calculable because none of them had progression at the final time point for the assessment.
|
SECONDARY outcome
Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entryPopulation: Only patients with measurable disease response were included in this analysis.
Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.
Outcome measures
| Measure |
Ixabepilone - no Prior Chemo
n=5 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Prior Taxane
n=2 Participants
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
Ixabepilone - Two Prior Chemo
All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
|
|---|---|---|---|
|
Duration of Measurable Disease Response
|
5.1 Months
Interval 3.0 to 9.4
|
3.7 Months
The lower and upper limits of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for the assessment.
|
—
|
Adverse Events
Ixabepilone
Serious events: 90 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone
n=123 participants at risk
All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
8/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukopenia
|
22.0%
27/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphopenia
|
3.3%
4/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutropenia
|
17.9%
22/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Thrombocytopenia
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
PVCs
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
22.8%
28/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.8%
12/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
6/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
5.7%
7/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
7/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
3/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ Gr0-2 neutropenia, catheter
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ Gr0-2 neutropenia, lung
|
2.4%
3/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ Gr0-2 neutropenia, skin
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Duodenum, hemorrhage
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ataxia
|
3.3%
4/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
10.6%
13/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
26.0%
32/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Syncope
|
3.3%
4/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
2.4%
3/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathic, pain
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain NOS
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.81%
1/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.6%
2/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Ixabepilone
n=123 participants at risk
All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
91.1%
112/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukopenia
|
68.3%
84/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutropenia
|
41.5%
51/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Thrombocytopenia
|
22.0%
27/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
8.9%
11/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
72.4%
89/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
17.1%
21/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
13.8%
17/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.6%
45/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
11.4%
14/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.9%
11/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
56/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.6%
29/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
10/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
33.3%
41/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
12.2%
15/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
56/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Taste disturbance
|
25.2%
31/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
30/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema: limb
|
12.2%
15/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
ALT increased
|
8.9%
11/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
AST increased
|
24.4%
30/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Bilirubin increased
|
8.9%
11/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine increased
|
14.6%
18/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
8.9%
11/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
18.7%
23/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
21.1%
26/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
53.7%
66/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
20.3%
25/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
7.3%
9/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
5.7%
7/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain NOS
|
11.4%
14/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
14/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
21/123 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60