Trial Outcomes & Findings for Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery (NCT NCT00848016)
NCT ID: NCT00848016
Last Updated: 2014-05-07
Results Overview
In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2014-05-07
Participant Flow
This study opened on 3/17/2009 and accrued 29 participants before being permanently closed 8/03/2011.
All 29 participants are off treatment, and all participants are evaluable for response and for adverse responses.
Participant milestones
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 Participants
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsIn order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 Participants
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
|
0 percentage of participants
No confidence interval was estimated due to a lack of response.
|
SECONDARY outcome
Timeframe: From registration to date of last follow-up or death due to any cause, assessed up to 2 yearsThe overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 Participants
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
8.5 months
Interval 5.0 to 9.8
|
SECONDARY outcome
Timeframe: From registration to progression or death, whichever occurs first, up to 2 years.The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 Participants
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
1.9 months
Interval 1.8 to 2.0
|
Adverse Events
Treatment (R-(-)-Gossypol Acetic Acid)
Serious events: 11 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 participants at risk
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.9%
2/29 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
1/29 • Number of events 1
|
|
Endocrine disorders
Adrenal insufficiency
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Cardiac troponin T increased
|
6.9%
2/29 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
10.3%
3/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
3.4%
1/29 • Number of events 1
|
|
Vascular disorders
Hypertension
|
6.9%
2/29 • Number of events 2
|
Other adverse events
| Measure |
Treatment (R-(-)-Gossypol Acetic Acid)
n=29 participants at risk
Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
72.4%
21/29 • Number of events 57
|
|
Cardiac disorders
Arrhythmia
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Sinus arrhythmia
|
3.4%
1/29 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
10.3%
3/29 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
48.3%
14/29 • Number of events 20
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
9/29 • Number of events 18
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
24.1%
7/29 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 6
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 2
|
|
General disorders
Edema limbs
|
6.9%
2/29 • Number of events 5
|
|
General disorders
Fatigue
|
27.6%
8/29 • Number of events 13
|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
3/29 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
24.1%
7/29 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
20.7%
6/29 • Number of events 7
|
|
Investigations
Bilirubin increased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
Cardiac troponin I increased
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Cardiac troponin T increased
|
10.3%
3/29 • Number of events 4
|
|
Investigations
Creatinine increased
|
17.2%
5/29 • Number of events 7
|
|
Investigations
Laboratory test abnormal
|
10.3%
3/29 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
6.9%
2/29 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
6.9%
2/29 • Number of events 5
|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
1/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.4%
1/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
10.3%
3/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
31.0%
9/29 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.9%
2/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
10.3%
3/29 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.9%
2/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Number of events 3
|
|
Nervous system disorders
Taste alteration
|
3.4%
1/29 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.4%
1/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.9%
2/29 • Number of events 3
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Number of events 2
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60