Trial Outcomes & Findings for A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer (NCT NCT00633087)

NCT ID: NCT00633087

Last Updated: 2023-12-22

Results Overview

A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2023-12-22

Participant Flow

Twelve subjects were enrolled from April 2007 through June 2009 at The Cancer Institute of New Jersey, a comprehensive cancer center.

Participant milestones

Measure	2-deoxyglucose 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer

Baseline characteristics by cohort

Measure	2-deoxyglucose n=12 Participants 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: No data collected

A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	2-deoxyglucose n=12 Participants 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
Progression-free Survival	9 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	2-deoxyglucose n=12 Participants 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
Overall Survival	7 Participants

Adverse Events

2-deoxyglucose

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	2-deoxyglucose n=12 participants at risk 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
General disorders Pain - Back	8.3% 1/12 • Number of events 1 • 5 years
General disorders Fatigue (asthenia, lethargy, malaise)	8.3% 1/12 • Number of events 1 • 5 years
General disorders Pain (right lower quadrant)	8.3% 1/12 • Number of events 1 • 5 years

Other adverse events

Measure	2-deoxyglucose n=12 participants at risk 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
General disorders Fatigue (asthenia, lethargy, malaise)	41.7% 5/12 • Number of events 8 • 5 years
Cardiac disorders Prolonged QTc interval	33.3% 4/12 • Number of events 4 • 5 years
Cardiac disorders Conduction abnormality/atrioventricular heart block	8.3% 1/12 • Number of events 3 • 5 years
General disorders Pain	16.7% 2/12 • Number of events 2 • 5 years
General disorders Pain - Back	8.3% 1/12 • Number of events 2 • 5 years
General disorders Pain - Chest wall	8.3% 1/12 • Number of events 1 • 5 years
General disorders Pain - Pelvis	8.3% 1/12 • Number of events 1 • 5 years
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • 5 years
Gastrointestinal disorders Gastrointestinal - Other	8.3% 1/12 • Number of events 1 • 5 years
Blood and lymphatic system disorders Platelets	8.3% 1/12 • Number of events 2 • 5 years
Skin and subcutaneous tissue disorders Rash: acne/acneiform	8.3% 1/12 • Number of events 1 • 5 years
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory (nose)	8.3% 1/12 • Number of events 1 • 5 years
Blood and lymphatic system disorders Edema: limb	8.3% 1/12 • Number of events 1 • 5 years
Investigations Alkaline phosphatase	8.3% 1/12 • Number of events 1 • 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	8.3% 1/12 • Number of events 1 • 5 years

Additional Information

Dr. Robert DiPaola, MD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-8675

Email: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

Results disclosure agreements

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