Trial Outcomes & Findings for Vidaza to Restore Hormone Thx Prostate (NCT NCT00384839)

Last Updated: 2018-10-25

Results Overview

To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time \>3= months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Until progression or up to a maximum of 12 cycles

Results posted on

2018-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Vidaza azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Overall Study STARTED	36
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Vidaza azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Overall Study Adverse Event	4
Overall Study Investigator Request	1
Overall Study Patient Request	1
Overall Study Ineligible	2

Baseline Characteristics

Vidaza to Restore Hormone Thx Prostate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vidaza n=36 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Age, Continuous	71.1 years STANDARD_DEVIATION 9.19 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	33 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Until progression or up to a maximum of 12 cycles

Population: Evaluable population

Outcome measures

Outcome measures
Measure	Vidaza n=34 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Percentage of Patients With PSA Doubling Time >=3 Months.	55.8 % of patients with PSA-DT>= 3 months Interval 37.9 to 72.8

SECONDARY outcome

Timeframe: Every 8 weeks for 1 year.

Population: Evaluable population

Complete PSA Response defined as complete normalization of PSA maintained for at least 4 weeks, and partial PSA response defined as a decrease in PSA level of at least 50% from baseline level maintained for at least 4 weeks.

Outcome measures

Outcome measures
Measure	Vidaza n=34 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
PSA Response Rate	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Every 8 weeks for 1 year.

Population: Only for patients with lesions evaluable by RECIST criteria at baseline.

ORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Vidaza n=13 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Objective Response Rate by Recist (ORR)	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 1.5 year.

Population: ITT population

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Vidaza n=36 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Progression-free Survival	12.4 weeks Interval 2.1 to 70.3

SECONDARY outcome

Timeframe: Up to 1 year.

Population: ITT population

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

Outcome measures

Outcome measures
Measure	Vidaza n=36 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
1-year Overall Survival (OS)	0.73 Probability of Survival at 1-year Interval 0.54 to 0.85

SECONDARY outcome

Timeframe: Up to 1 year.

Population: Patients with HbF measurements.

Time from baseline to maximal fetal hemoglobin (HbF).

Outcome measures

Outcome measures
Measure	Vidaza n=14 Participants azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Changes in Fetal Hemoglobin (HbF) With Time.	12.7 weeks Interval 8.4 to 26.6

Adverse Events

Vidaza

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vidaza n=34 participants at risk azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Gastrointestinal disorders NAUSEA	2.9% 1/34 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	2.9% 1/34 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Other adverse events

Other adverse events
Measure	Vidaza n=34 participants at risk azacitidine for injectable suspension : Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Blood and lymphatic system disorders ANEMIA	20.6% 7/34 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders ANOREXIA	20.6% 7/34 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders CONSTIPATION	38.2% 13/34 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders CREATININE SERUM INCREASED	5.9% 2/34 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DIARRHEA	8.8% 3/34 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders FATIGUE	41.2% 14/34 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders INJECTION SITE PAIN	5.9% 2/34 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders INJECTION SITE REACTION	26.5% 9/34 • Number of events 19 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders LEUCOPENIA	8.8% 3/34 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA	32.4% 11/34 • Number of events 14 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Nervous system disorders NEUROPATHY	5.9% 2/34 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders NEUTROPENIA	17.6% 6/34 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders PRURITUS	8.8% 3/34 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders RASH	8.8% 3/34 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders THROMBOCYTOPENIA	5.9% 2/34 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	29.4% 10/34 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEAKNESS	8.8% 3/34 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Additional Information

Dr. Guru Sonpavde

Texas Oncology, P.A

Phone: (281) 332-7505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place