Trial Outcomes & Findings for Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer (NCT NCT01533246)
NCT ID: NCT01533246
Last Updated: 2015-03-13
Results Overview
Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-03-13
Participant Flow
18 patients were entered into the trial between February 2012 and April 2012 form local medical hospitals. One patient was considered ineligible and has been excluded from all analyses.
Participant milestones
| Measure |
Treatment (Linsitinib)
Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Linsitinib)
Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Customized
50-59 years
|
2 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
7 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients that received treatment
Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
PSA Response Analyzed Using the PCWG2 Definition
PSA Partial Response
|
1 participants
|
|
PSA Response Analyzed Using the PCWG2 Definition
PSA No Response
|
16 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients that received treatment
Number of patients with at least possibly related to treatment toxicities grade 3 or higher based on Common Terminology Criteria for Adverse Events.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Incidence of Toxicities Based on CTCAE Version 4.0 Criteria
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with soft tissue disease only
RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=10 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Patients With Bidimensional Measurable Disease RECIST-based Response
Partial Response
|
1 participants
|
|
Number of Patients With Bidimensional Measurable Disease RECIST-based Response
Stable Disease
|
8 participants
|
|
Number of Patients With Bidimensional Measurable Disease RECIST-based Response
Progression
|
1 participants
|
SECONDARY outcome
Timeframe: assessed up to 12 weeksPopulation: Patients that received treatment.
TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition
|
1.8 months
Interval 0.9 to 2.8
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients that received treatment
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival Based on the RECIST v1.1
|
3.7 Months
Interval 3.0 to 6.7
|
SECONDARY outcome
Timeframe: assessed up to 2 yearsPopulation: Patients that received treatment
Progression Free survival (PFS) time was measured as the time from the date of on study up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression Free Survival
|
4.7 Months
Interval 3.0 to 6.7
|
Adverse Events
Treatment (Linsitinib)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Linsitinib)
n=17 participants at risk
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Duodenitis
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Urinary Retention
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
Other adverse events
| Measure |
Treatment (Linsitinib)
n=17 participants at risk
Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
64.7%
11/17 • Number of events 15 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Creatinine increased
|
47.1%
8/17 • Number of events 12 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Alanine aminotransferase increased
|
41.2%
7/17 • Number of events 8 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Lymphocyte count decreased
|
35.3%
6/17 • Number of events 10 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
29.4%
5/17 • Number of events 8 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Platelet count decreased
|
17.6%
3/17 • Number of events 3 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Weight loss
|
17.6%
3/17 • Number of events 4 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
White blood cell decreased
|
11.8%
2/17 • Number of events 5 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • Number of events 8 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Constipation
|
23.5%
4/17 • Number of events 6 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Number of events 3 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • Number of events 4 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Bloating
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Ileus
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
64.7%
11/17 • Number of events 18 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
23.5%
4/17 • Number of events 5 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
2/17 • Number of events 6 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
General disorders
Fatigue
|
58.8%
10/17 • Number of events 16 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
General disorders
Non-cardiac chest pain
|
17.6%
3/17 • Number of events 3 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
General disorders
Irritability
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
41.2%
7/17 • Number of events 7 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • Number of events 5 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral thigh cramps intermittent
|
5.9%
1/17 • Number of events 12 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Infections and infestations
Urinary tract infection
|
23.5%
4/17 • Number of events 5 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Infections and infestations
Upper respiratory infection
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Renal calculi
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Renal and urinary disorders
Urinary urgency
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Vascular disorders
Hot flashes
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • Number of events 1 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Reproductive system and breast disorders
Penile pain
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
|
Reproductive system and breast disorders
Penile hemorrhage
|
5.9%
1/17 • Number of events 2 • Patients were followed for adverse events from start of treatment to 30 days after treatment up to a period of 6 months
|
Additional Information
Dr. Jorge Garcia
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-7774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60