Trial Outcomes & Findings for Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer (NCT NCT00638378)
NCT ID: NCT00638378
Last Updated: 2018-02-12
Results Overview
A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.
TERMINATED
PHASE2
22 participants
Assessed monthly from Baseline until the end of study (up to 8 months)
2018-02-12
Participant Flow
Participant milestones
| Measure |
Ruxolitinib
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Ruxolitinib
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease progression
|
15
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Ruxolitinib
n=22 Participants
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed monthly from Baseline until the end of study (up to 8 months)Population: The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.
A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.
Outcome measures
| Measure |
Ruxolitinib
n=22 Participants
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Number of Participants With a Prostate-specific Antigen Response
|
0 participants
|
PRIMARY outcome
Timeframe: From Baseline through to the end of study (up to 8 months)Population: The Safety population included all enrolled patients who received at least 1 dose of study medication.
A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Outcome measures
| Measure |
Ruxolitinib
n=22 Participants
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Number of Participants With Adverse Events (AE)
Any adverse event
|
22 Participants
|
|
Number of Participants With Adverse Events (AE)
Treatment-related adverse event
|
16 Participants
|
|
Number of Participants With Adverse Events (AE)
Serious adverse event
|
9 Participants
|
|
Number of Participants With Adverse Events (AE)
Grade 3 or 4 adverse event
|
13 Participants
|
|
Number of Participants With Adverse Events (AE)
Discontinued study medication due to adverse event
|
4 Participants
|
|
Number of Participants With Adverse Events (AE)
Discontinued study due to adverse events
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline until the end of study (up to 8 months).Population: According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.
The time from first dosing day to the date of disease progression: * Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results). * Development of unequivocal new lesions on bone scan without clinical suspicion of a "flare" reaction. * In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value. * In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline through the end of study (up to 8 months)Population: According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.
Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
Outcome data not reported
Adverse Events
Ruxolitinib
Serious adverse events
| Measure |
Ruxolitinib
n=22 participants at risk
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
2/22
|
|
Cardiac disorders
Cardiac arrest
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.5%
1/22
|
|
Infections and infestations
Sepsis
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Overdose
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
4.5%
1/22
|
|
Renal and urinary disorders
Hydronephrosis
|
4.5%
1/22
|
|
Renal and urinary disorders
Renal failure
|
4.5%
1/22
|
Other adverse events
| Measure |
Ruxolitinib
n=22 participants at risk
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
54.5%
12/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.2%
4/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
2/22
|
|
Gastrointestinal disorders
Constipation
|
36.4%
8/22
|
|
Gastrointestinal disorders
Nausea
|
36.4%
8/22
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
4/22
|
|
Gastrointestinal disorders
Abdominal distension
|
13.6%
3/22
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
2/22
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
2/22
|
|
General disorders
Fatigue
|
40.9%
9/22
|
|
General disorders
Oedema peripheral
|
40.9%
9/22
|
|
General disorders
Pyrexia
|
13.6%
3/22
|
|
General disorders
Chills
|
9.1%
2/22
|
|
General disorders
Oedema
|
9.1%
2/22
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
2/22
|
|
Investigations
Blood lactate dehydrogenase increased
|
27.3%
6/22
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
2/22
|
|
Investigations
Weight decreased
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Anorexia
|
22.7%
5/22
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.2%
4/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22
|
|
Nervous system disorders
Headache
|
13.6%
3/22
|
|
Psychiatric disorders
Anxiety
|
18.2%
4/22
|
|
Psychiatric disorders
Depression
|
9.1%
2/22
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22
|
|
Renal and urinary disorders
Dysuria
|
9.1%
2/22
|
|
Renal and urinary disorders
Haematuria
|
9.1%
2/22
|
|
Renal and urinary disorders
Pollakiuria
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
4/22
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.6%
3/22
|
|
Vascular disorders
Hypotension
|
9.1%
2/22
|
Additional Information
Study Director
Incyte Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER