Trial Outcomes & Findings for Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer (NCT NCT00348595)

NCT ID: NCT00348595

Last Updated: 2019-04-12

Results Overview

Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: 6 months post-intervention
• Results posted on: 2019-04-12

Participant Flow

17 subjects were screen failures

Participant milestones

Measure	Revlimid 5mg/Day One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Study STARTED	26	34
Overall Study COMPLETED	21	26
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	Revlimid 5mg/Day One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Study Adverse Event	5	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Revlimid 5mg/Day n=26 Participants One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.	Revlimid 25mg/Day n=34 Participants One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.	Total n=60 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 7.1 • n=26 Participants	63.1 years STANDARD_DEVIATION 7.2 • n=34 Participants	63.4 years STANDARD_DEVIATION 7.1 • n=60 Participants
Sex: Female, Male Female	0 Participants n=26 Participants	0 Participants n=34 Participants	0 Participants n=60 Participants
Sex: Female, Male Male	26 Participants n=26 Participants	34 Participants n=34 Participants	60 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 participants n=26 Participants	34 participants n=34 Participants	60 participants n=60 Participants
Gleason score	7.1 units on a scale STANDARD_DEVIATION 1.0 • n=26 Participants	7.3 units on a scale STANDARD_DEVIATION 1.1 • n=34 Participants	7.2 units on a scale STANDARD_DEVIATION 1.05 • n=60 Participants
Local therapy Radical prostatectomy	12 Participants n=26 Participants	12 Participants n=34 Participants	24 Participants n=60 Participants
Local therapy Radiation therapy	4 Participants n=26 Participants	8 Participants n=34 Participants	12 Participants n=60 Participants
Local therapy Surgery and Radiation therapy	10 Participants n=26 Participants	14 Participants n=34 Participants	24 Participants n=60 Participants
Local therapy Prior androgen deprivation therapy	8 Participants n=26 Participants	11 Participants n=34 Participants	19 Participants n=60 Participants
Serum testosterone	374 (ng/dL) n=26 Participants	342 (ng/dL) n=34 Participants	358 (ng/dL) n=60 Participants
Prostate Specific Antigen (PSA)	11.9 ng/mL STANDARD_DEVIATION 11.9 • n=26 Participants	12.4 ng/mL STANDARD_DEVIATION 13.6 • n=34 Participants	12.2 ng/mL STANDARD_DEVIATION 12.8 • n=60 Participants
PSA doubling time (PSADT) < 3 months	6 Participants n=26 Participants	10 Participants n=34 Participants	16 Participants n=60 Participants
PSA doubling time (PSADT) 3-8.9 months	13 Participants n=26 Participants	16 Participants n=34 Participants	29 Participants n=60 Participants
PSA doubling time (PSADT) ≥ 9 months	7 Participants n=26 Participants	8 Participants n=34 Participants	15 Participants n=60 Participants
Pre-treatment PSA slopes	0.16 log PSA/month n=26 Participants	0.18 log PSA/month n=34 Participants	0.17 log PSA/month n=60 Participants

PRIMARY outcome

Timeframe: 6 months post-intervention

Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0

Outcome measures

Measure	Revlimid 5mg/Day n=26 Participants One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day n=34 Participants One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Safety, Feasibility and Tolerance of Revlimid as Assessed by Number of Participants Experiencing Grade 3 and 4 Adverse Events.	3 Participants	10 Participants

PRIMARY outcome

Timeframe: 6 months post-intervention

Number of participants with greater than or equal to 25% increase in PSA at 6 months

Outcome measures

Measure	Revlimid 5mg/Day n=26 Participants One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day n=34 Participants One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Number of Participants With Prostate-specific Antigen (PSA) Progression	7 Participants	5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months post-intervention

Mean change in PSA slope from baseline to 6 months. PSA slope was calculated using the regression of log PSA over 6 months in each patient. A negative mean change in PSA slope reflects a better outcome.

Outcome measures

Measure	Revlimid 5mg/Day n=26 Participants One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day n=34 Participants One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Change in of PSA Slope	-0.033 log PSA Interval -0.11 to 0.04	-0.172 log PSA Interval -0.24 to -0.11

SECONDARY outcome

Timeframe: Day 21 of second treatment cycle

Population: Data was only evaluable in 20/26 and 27/34 participants from the 5mg and 25mg arms, respectively.

Mean plasma concentration (ng/mL) of Revilimid at steady state (Day 21 of second treatment cycle)

Outcome measures

Measure	Revlimid 5mg/Day n=20 Participants One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).	Revlimid 25mg/Day n=27 Participants One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Plasma Concentration of Revilimid at Steady State	12.67 ng/mL Interval 6.1 to 19.2	65.14 ng/mL Interval 24.3 to 106.0

Adverse Events

Revlimid 5mg/Day

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Revlimid 25mg/Day

Serious events: 10 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Revlimid 5mg/Day n=26 participants at risk One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.	Revlimid 25mg/Day n=34 participants at risk One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
Blood and lymphatic system disorders Neutropenia	0.00% 0/26 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Vascular disorders venous thromboembolism	7.7% 2/26 • Number of events 2 • Collected monthly, up to 44 months	5.9% 2/34 • Number of events 2 • Collected monthly, up to 44 months
Nervous system disorders Fatigue	3.8% 1/26 • Number of events 1 • Collected monthly, up to 44 months	2.9% 1/34 • Number of events 1 • Collected monthly, up to 44 months
Skin and subcutaneous tissue disorders Severe Rash	0.00% 0/26 • Collected monthly, up to 44 months	5.9% 2/34 • Number of events 2 • Collected monthly, up to 44 months

Other adverse events

Measure	Revlimid 5mg/Day n=26 participants at risk One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.	Revlimid 25mg/Day n=34 participants at risk One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
Blood and lymphatic system disorders anemia	26.9% 7/26 • Number of events 7 • Collected monthly, up to 44 months	29.4% 10/34 • Number of events 10 • Collected monthly, up to 44 months
Gastrointestinal disorders Constipation	38.5% 10/26 • Number of events 10 • Collected monthly, up to 44 months	44.1% 15/34 • Number of events 15 • Collected monthly, up to 44 months
Nervous system disorders Fatigue	46.2% 12/26 • Number of events 12 • Collected monthly, up to 44 months	85.3% 29/34 • Number of events 29 • Collected monthly, up to 44 months
Metabolism and nutrition disorders Hyperglycemia	42.3% 11/26 • Number of events 11 • Collected monthly, up to 44 months	41.2% 14/34 • Number of events 14 • Collected monthly, up to 44 months
Investigations Increased of SGOT	7.7% 2/26 • Number of events 2 • Collected monthly, up to 44 months	23.5% 8/34 • Number of events 8 • Collected monthly, up to 44 months
Nervous system disorders Muscular Cramping	19.2% 5/26 • Number of events 5 • Collected monthly, up to 44 months	41.2% 14/34 • Number of events 14 • Collected monthly, up to 44 months
Blood and lymphatic system disorders Lymphopenia	3.8% 1/26 • Number of events 1 • Collected monthly, up to 44 months	23.5% 8/34 • Number of events 8 • Collected monthly, up to 44 months
Blood and lymphatic system disorders Neutropenia	19.2% 5/26 • Number of events 5 • Collected monthly, up to 44 months	26.5% 9/34 • Number of events 9 • Collected monthly, up to 44 months
Skin and subcutaneous tissue disorders Pruritus	30.8% 8/26 • Number of events 8 • Collected monthly, up to 44 months	44.1% 15/34 • Number of events 15 • Collected monthly, up to 44 months
Skin and subcutaneous tissue disorders Rash	26.9% 7/26 • Number of events 7 • Collected monthly, up to 44 months	44.1% 15/34 • Number of events 15 • Collected monthly, up to 44 months
Blood and lymphatic system disorders Thrombocytopenia	100.0% 4/4 • Number of events 4 • Collected monthly, up to 44 months	23.5% 8/34 • Number of events 8 • Collected monthly, up to 44 months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/26 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Gastrointestinal disorders Dysphagia	0.00% 0/26 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Gastrointestinal disorders Anal Pain	3.8% 1/26 • Number of events 1 • Collected monthly, up to 44 months	0.00% 0/34 • Collected monthly, up to 44 months
Gastrointestinal disorders Abdominal Pain	11.5% 3/26 • Number of events 3 • Collected monthly, up to 44 months	17.6% 6/34 • Number of events 6 • Collected monthly, up to 44 months
Musculoskeletal and connective tissue disorders Back Pain	15.4% 4/26 • Number of events 4 • Collected monthly, up to 44 months	5.9% 2/34 • Number of events 2 • Collected monthly, up to 44 months
Eye disorders Blurred Vision	3.8% 1/26 • Number of events 1 • Collected monthly, up to 44 months	5.9% 2/34 • Number of events 2 • Collected monthly, up to 44 months
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • Number of events 2 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Psychiatric disorders Depression	0.00% 0/26 • Collected monthly, up to 44 months	2.9% 1/34 • Number of events 1 • Collected monthly, up to 44 months
Gastrointestinal disorders Diarrhea	7.7% 2/26 • Number of events 2 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Nervous system disorders Dizziness	15.4% 4/26 • Number of events 4 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Eye disorders Dry Eye	7.7% 2/26 • Number of events 2 • Collected monthly, up to 44 months	5.9% 2/34 • Number of events 2 • Collected monthly, up to 44 months
Gastrointestinal disorders Dry Mouth	3.8% 1/26 • Number of events 1 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Skin and subcutaneous tissue disorders Dry Skin	15.4% 4/26 • Number of events 4 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months
Vascular disorders Flushing	0.00% 0/26 • Collected monthly, up to 44 months	11.8% 4/34 • Number of events 4 • Collected monthly, up to 44 months
Nervous system disorders Headache	15.4% 4/26 • Number of events 4 • Collected monthly, up to 44 months	14.7% 5/34 • Number of events 5 • Collected monthly, up to 44 months

Additional Information

Mario Eisenberger

Johns Hopkins University School of Medicine

Phone: (410) 614-3511

Email: eisenma@jhmi.edu

Results disclosure agreements

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