Trial Outcomes & Findings for R-(-)-Gossypol and Androgen Ablation Therapy in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer (NCT NCT00666666)
NCT ID: NCT00666666
Last Updated: 2014-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
3 years
Results posted on
2014-12-18
Participant Flow
Patients were recruited from April 2008 through July 2010, from four academic medical centers.
There are no pre-assignment requirements.
Participant milestones
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
R-(-)-Gossypol and Androgen Ablation Therapy in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
61.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
|
Gleason Score
Gleason Score 6
|
1 participants
n=5 Participants
|
|
Gleason Score
Gleason Score 7
|
13 participants
n=5 Participants
|
|
Gleason Score
Gleason Score 8
|
12 participants
n=5 Participants
|
|
Gleason Score
Gleason Score 9
|
24 participants
n=5 Participants
|
|
Gleason Score
Gleason Score 10
|
3 participants
n=5 Participants
|
|
Gleason Score
Not assessed
|
2 participants
n=5 Participants
|
|
Metastatic disease
Visceral metastases
|
3 participants
n=5 Participants
|
|
Metastatic disease
Bone/node metastases
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 Participants
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 Participants
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 Participants
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Percentage of Patients With Overall PSA < 4.0 ng/mL
|
60 percentage of participants
|
Adverse Events
AT101 (R-(-)-Gossypol Acetic Acid)
Serious events: 13 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 participants at risk
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Eye disorders
Eye disorders - optic neuritis
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Ileus
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Infections and infestations
Infections and infestations - urosepsis
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - left total hip arthroplasty
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
1/55 • Number of events 1 • 8 months
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1 • 8 months
|
Other adverse events
| Measure |
AT101 (R-(-)-Gossypol Acetic Acid)
n=55 participants at risk
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
36.4%
20/55 • Number of events 28 • 8 months
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
14/55 • Number of events 22 • 8 months
|
|
Gastrointestinal disorders
Constipation
|
23.6%
13/55 • Number of events 14 • 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
21.8%
12/55 • Number of events 18 • 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.5%
8/55 • Number of events 11 • 8 months
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
4/55 • Number of events 4 • 8 months
|
|
General disorders
Fatigue
|
58.2%
32/55 • Number of events 42 • 8 months
|
|
General disorders
Edema limbs
|
9.1%
5/55 • Number of events 5 • 8 months
|
|
General disorders
Chills
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
General disorders
Pain
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
49.1%
27/55 • Number of events 42 • 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
10/55 • Number of events 12 • 8 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.5%
8/55 • Number of events 9 • 8 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.9%
6/55 • Number of events 10 • 8 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
5/55 • Number of events 7 • 8 months
|
|
Metabolism and nutrition disorders
Acidosis
|
7.3%
4/55 • Number of events 5 • 8 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.5%
3/55 • Number of events 4 • 8 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.5%
3/55 • Number of events 4 • 8 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
34.5%
19/55 • Number of events 29 • 8 months
|
|
Nervous system disorders
Dizziness
|
12.7%
7/55 • Number of events 8 • 8 months
|
|
Nervous system disorders
Headache
|
10.9%
6/55 • Number of events 6 • 8 months
|
|
Nervous system disorders
Dysgeusia
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.5%
3/55 • Number of events 4 • 8 months
|
|
Investigations
Alanine aminotransferase increased
|
41.8%
23/55 • Number of events 35 • 8 months
|
|
Investigations
Aspartate aminotransferase increased
|
30.9%
17/55 • Number of events 26 • 8 months
|
|
Investigations
Creatinine increased
|
18.2%
10/55 • Number of events 17 • 8 months
|
|
Investigations
Platelet count decreased
|
10.9%
6/55 • Number of events 15 • 8 months
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
5/55 • Number of events 6 • 8 months
|
|
Investigations
White blood cell decreased
|
9.1%
5/55 • Number of events 12 • 8 months
|
|
Investigations
Lymphocyte count decreased
|
5.5%
3/55 • Number of events 9 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
9/55 • Number of events 10 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.7%
7/55 • Number of events 9 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
6/55 • Number of events 11 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
4/55 • Number of events 4 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
22/55 • Number of events 34 • 8 months
|
|
Vascular disorders
Hot flashes
|
34.5%
19/55 • Number of events 22 • 8 months
|
|
Vascular disorders
Hypertension
|
10.9%
6/55 • Number of events 6 • 8 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.5%
8/55 • Number of events 8 • 8 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.5%
3/55 • Number of events 4 • 8 months
|
|
Renal and urinary disorders
Urinary frequency
|
14.5%
8/55 • Number of events 8 • 8 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Psychiatric disorders
Insomnia
|
10.9%
6/55 • Number of events 6 • 8 months
|
|
Psychiatric disorders
Depression
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
5/55 • Number of events 7 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
3/55 • Number of events 3 • 8 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.9%
6/55 • Number of events 6 • 8 months
|
Additional Information
Robert DiPaola, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60