Trial Outcomes & Findings for Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases (NCT NCT00390468)

Results Overview

Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.

Results posted on

2014-05-28

Participant Flow

Recruitment at UT MD Anderson Cancer Medical Clinic from October 24, 2006 to January 8, 2008.

Participants must have had at least one prior taxane based regimen but no prior known Platelet Derived Growth Factor Receptor (PDGFR) inhibitor therapy was permitted.

Participant milestones

Participant milestones
Measure	Tandutinib (MLN518) 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tandutinib (MLN518) 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
Overall Study Protocol Violation	2
Overall Study Lack of Efficacy	1

Baseline Characteristics

Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tandutinib (MLN518) n=18 Participants 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
Age, Customized	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.

Population: Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.

Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.

Outcome measures

Outcome measures
Measure	Tandutinib (MLN518) n=18 Participants 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
8-week Freedom-From-Progression (FFP) Participants Progression Free at 8 Weeks	2 participants Interval 3.0 to 40.0
8-week Freedom-From-Progression (FFP) Evaluable Participants at 8 Weeks	15 participants

Adverse Events

Tandutinib (MLN518)

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tandutinib (MLN518) n=15 participants at risk 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
Nervous system disorders Cranial Nerve III	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Blood and lymphatic system disorders platelet count low	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Cardiac disorders hypertension	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Immune system disorders infection with normal ANC	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Respiratory, thoracic and mediastinal disorders pulmonary obstruction	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Renal and urinary disorders hemmorhage GU urinary NOS	6.7% 1/15 • Number of events 1 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.

Other adverse events

Other adverse events
Measure	Tandutinib (MLN518) n=15 participants at risk 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
Gastrointestinal disorders nausea	100.0% 15/15 • Number of events 22 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Gastrointestinal disorders vomiting	100.0% 15/15 • Number of events 16 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
General disorders fatigue	100.0% 15/15 • Number of events 23 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Blood and lymphatic system disorders anemia	100.0% 15/15 • Number of events 26 • 14 months The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.

Additional Information

Quality Assurance Specialist

UT MD Anderson Cancer Center

Phone: 713-792-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60