Trial Outcomes & Findings for Metformin in Castration-Resistant Prostate Cancer (NCT NCT01215032)

NCT ID: NCT01215032

Last Updated: 2017-05-15

Results Overview

Percent change in PSA from baseline to 12 weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Approximately 12 weeks
• Results posted on: 2017-05-15

Participant Flow

Participant milestones

Measure	Metformin This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle
Overall Study STARTED	21
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Metformin This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	17

Baseline Characteristics

Metformin in Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Metformin n=21 Participants This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	65.86 years STANDARD_DEVIATION 7.23 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 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	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 12 weeks

Percent change in PSA from baseline to 12 weeks.

Outcome measures

Measure	Metformin n=21 Participants This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles	Abnormal Baseline Hemoglobin A1c Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
PSA (Prostate Specific Antigen) Response	161 percentage of baseline PSA Interval 96.1 to 309.5	—

SECONDARY outcome

Timeframe: 12 weeks

PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.

Outcome measures

Measure	Metformin n=21 Participants This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles	Abnormal Baseline Hemoglobin A1c Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
Number of Participants With PSA Response	0 Participants	—

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected for this outcome measure because blood (plasma) samples were never run on the Metabolon platform, as the study was terminated early.

To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Participants were stratified based on baseline hemoglobin A1c. HbA1c \< 6.0 is considered normal; HbA1c \>/= 6.0 is considered abnormal.

To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.

Outcome measures

Measure	Metformin n=15 Participants This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles	Abnormal Baseline Hemoglobin A1c n=6 Participants Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
Percent Maintaining Glycemic Control	15 Participants	6 Participants

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metformin n=21 participants at risk This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle
Endocrine disorders Hypothyroidism	4.8% 1/21
Eye disorders cataract	4.8% 1/21
Gastrointestinal disorders abdominal pain	4.8% 1/21
Gastrointestinal disorders diarrhea	47.6% 10/21
Gastrointestinal disorders flatulence	9.5% 2/21
Gastrointestinal disorders frequent bowel movements	4.8% 1/21
Gastrointestinal disorders nausea	19.0% 4/21
Gastrointestinal disorders vomiting	4.8% 1/21
General disorders chills	4.8% 1/21
General disorders fatigue	19.0% 4/21
General disorders fever	4.8% 1/21
General disorders Generalized achiness	4.8% 1/21
General disorders Non-cardiac chest pain	4.8% 1/21
Metabolism and nutrition disorders anorexia	14.3% 3/21
Metabolism and nutrition disorders hyperglycemia	4.8% 1/21
Metabolism and nutrition disorders Vitamin D deficiency	4.8% 1/21
Musculoskeletal and connective tissue disorders Back pain	4.8% 1/21
Musculoskeletal and connective tissue disorders Bone pain	4.8% 1/21
Musculoskeletal and connective tissue disorders Buttock pain	4.8% 1/21
Musculoskeletal and connective tissue disorders Chest wall pain	4.8% 1/21
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 1/21
Musculoskeletal and connective tissue disorders Numbness in Toes	4.8% 1/21
Musculoskeletal and connective tissue disorders Numbness - buttocks	4.8% 1/21
Renal and urinary disorders Urinary frequency	4.8% 1/21
Renal and urinary disorders Urinary incontinence	4.8% 1/21
Respiratory, thoracic and mediastinal disorders Sore throat	4.8% 1/21
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 1/21
Vascular disorders Hypertension	4.8% 1/21

Additional Information

Maria Kempner

Mass General Hospital Cancer Center

Phone: 508.533.4132

Email: mkempner@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place