Trial Outcomes & Findings for S0916, MLN1202 in Treating Patients With Bone Metastases (NCT NCT01015560)
NCT ID: NCT01015560
Last Updated: 2018-08-09
Results Overview
Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
43 days
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
MLN 1202
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
Eligible and Analyzable
|
43
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
MLN 1202
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Not protocol specified
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
S0916, MLN1202 in Treating Patients With Bone Metastases
Baseline characteristics by cohort
| Measure |
MLN 1202
n=43 Participants
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 43 daysPopulation: Eligible and analyzable patients
Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.
Outcome measures
| Measure |
MLN 1202
n=43 Participants
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
uNTX Response Rate at 43 Days
|
14 percentage of participants
Interval 5.0 to 27.0
|
Adverse Events
MLN 1202
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MLN 1202
n=42 participants at risk
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
Other adverse events
| Measure |
MLN 1202
n=42 participants at risk
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.8%
10/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
General disorders
Edema limbs
|
11.9%
5/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
General disorders
Fatigue
|
35.7%
15/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Investigations
Alkaline phosphatase increased
|
9.5%
4/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Investigations
CD4 lymphocytes decreased
|
9.5%
4/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Investigations
Creatinine increased
|
19.0%
8/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Investigations
White blood cell decreased
|
9.5%
4/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.8%
10/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
7/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
4/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Vascular disorders
Hot flashes
|
11.9%
5/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
|
Vascular disorders
Hypertension
|
11.9%
5/42 • Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place