Trial Outcomes & Findings for 17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy (NCT NCT00118092)

Last Updated: 2017-04-18

Results Overview

Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. \> \> 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response.\> \> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2017-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Tanespimycin) Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Tanespimycin) Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Tanespimycin) n=15 Participants Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: All 15 eligible patients that started treatment were evaluated.

Outcome measures

Outcome measures
Measure	Treatment (Tanespimycin) n=15 Participants Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group	0 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All 15 eligible patients that started treatment were evaluated.

Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions. The proportion of confirmed responses will be estimated by the number of patients with confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Outcome measures

Outcome measures
Measure	Treatment (Tanespimycin) n=15 Participants Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Proportion of Overall Responses	0 percentage of responses Interval 0.0 to 22.0

SECONDARY outcome

Timeframe: From registration to death due to any cause, assessed up to 3 years

Population: All 15 eligible patients that started treatment were evaluated.

Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Tanespimycin) n=15 Participants Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	9.4 months Interval 2.7 to 17.7

SECONDARY outcome

Timeframe: From registration to documentation of disease progression, assessed up to 3 years

Population: All 15 eligible patients that started treatment were evaluated.

Disease-free survival time is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had progressed at the time of their death. In patients who have achieved a PSA response, we will assess the time to PSA progression. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Tanespimycin) n=15 Participants Patients receive 300 mg/m\^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. \> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Disease-free Survival	1.8 months Interval 1.3 to 3.4

SECONDARY outcome

Timeframe: From PSA response to time of progression, assessed up to 1 year

Population: No participants with PSA response or PSA control.

The distribution of this response duration will be estimated using the method of Kaplan-Meier. In patients whose PSA has declined from baseline by at least 30 %, "duration of PSA response" will be defined as the time from PSA response to time of progression. If a patient goes on to alternate therapy, they will be censored at the date they end treatment on this study. "Duration of PSA Control" is defined as the time from the date of the first 30% decline in PSA until an inflection point is identified. Inflection point is defined as the time to first consistent PSA increase, the point at which PSA began what becomes a continuous increase \> (retrospectively identified). The inflection point is the point at which disease control could assume to be lost.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Tanespimycin)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Tanespimycin) n=17 participants at risk Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Investigations Neutrophil count decreased	5.9% 1/17 • Number of events 2
Vascular disorders Thrombosis	5.9% 1/17 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Tanespimycin) n=17 participants at risk Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	82.4% 14/17 • Number of events 19
Cardiac disorders Premature ventricular contractions	5.9% 1/17 • Number of events 2
Cardiac disorders Sinus arrhythmia	5.9% 1/17 • Number of events 1
Cardiac disorders Sinus bradycardia	5.9% 1/17 • Number of events 1
Cardiac disorders Supraventricular extrasystoles	17.6% 3/17 • Number of events 4
Eye disorders Vision blurred	5.9% 1/17 • Number of events 1
Gastrointestinal disorders Abdominal pain	17.6% 3/17 • Number of events 4
Gastrointestinal disorders Constipation	23.5% 4/17 • Number of events 4
Gastrointestinal disorders Diarrhea	35.3% 6/17 • Number of events 6
Gastrointestinal disorders Flatulence	5.9% 1/17 • Number of events 1
Gastrointestinal disorders Mucositis oral	5.9% 1/17 • Number of events 1
Gastrointestinal disorders Nausea	47.1% 8/17 • Number of events 10
Gastrointestinal disorders Vomiting	23.5% 4/17 • Number of events 6
General disorders Fatigue	58.8% 10/17 • Number of events 15
General disorders Fever	5.9% 1/17 • Number of events 1
Infections and infestations Sinusitis	5.9% 1/17 • Number of events 1
Infections and infestations Skin infection	5.9% 1/17 • Number of events 1
Investigations Alanine aminotransferase increased	23.5% 4/17 • Number of events 6
Investigations Alkaline phosphatase increased	41.2% 7/17 • Number of events 10
Investigations Aspartate aminotransferase increased	47.1% 8/17 • Number of events 10
Investigations Electrocardiogram QTc interval prolonged	11.8% 2/17 • Number of events 2
Investigations Leukocyte count decreased	11.8% 2/17 • Number of events 3
Investigations Lymphocyte count decreased	29.4% 5/17 • Number of events 5
Investigations Neutrophil count decreased	5.9% 1/17 • Number of events 1
Investigations Platelet count decreased	23.5% 4/17 • Number of events 6
Investigations Weight loss	11.8% 2/17 • Number of events 2
Metabolism and nutrition disorders Anorexia	35.3% 6/17 • Number of events 7
Metabolism and nutrition disorders Blood glucose increased	41.2% 7/17 • Number of events 13
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1
Metabolism and nutrition disorders Serum albumin decreased	47.1% 8/17 • Number of events 11
Metabolism and nutrition disorders Serum calcium decreased	17.6% 3/17 • Number of events 5
Metabolism and nutrition disorders Serum phosphate decreased	5.9% 1/17 • Number of events 2
Metabolism and nutrition disorders Serum potassium decreased	5.9% 1/17 • Number of events 1
Metabolism and nutrition disorders Serum sodium decreased	11.8% 2/17 • Number of events 2
Musculoskeletal and connective tissue disorders Back pain	23.5% 4/17 • Number of events 4
Musculoskeletal and connective tissue disorders Bone pain	11.8% 2/17 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle weakness	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.9% 1/17 • Number of events 1
Nervous system disorders Headache	11.8% 2/17 • Number of events 3
Nervous system disorders Peripheral motor neuropathy	5.9% 1/17 • Number of events 1
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • Number of events 1
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1
Renal and urinary disorders Hemorrhage urinary tract	5.9% 1/17 • Number of events 1
Renal and urinary disorders Urinary frequency	5.9% 1/17 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • Number of events 1
Skin and subcutaneous tissue disorders Body odor	17.6% 3/17 • Number of events 4
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.9% 1/17 • Number of events 1
Vascular disorders Flushing	5.9% 1/17 • Number of events 1

Additional Information

Elisabeth Iljas Heath, M.D.

Karmanos Cancer Institute at Wayne State University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60