Trial Outcomes & Findings for Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas (NCT NCT02987959)
NCT ID: NCT02987959
Last Updated: 2022-10-14
Results Overview
Progression free rate will be determined by determining the number of patients with complete response, partial response and stable disease
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
12 weeks post-treatment
Results posted on
2022-10-14
Participant Flow
Participant milestones
| Measure |
TAK-228 Treatment
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
TAK-228 Treatment
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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|---|---|
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Overall Study
Grantor stopped supply of drugs
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6
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Baseline Characteristics
Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas
Baseline characteristics by cohort
| Measure |
TAK-228 Treatment
n=6 Participants
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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4 Participants
n=5 Participants
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
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Age, Continuous
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53 years
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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6 participants
n=5 Participants
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Tumor type
Leiomyosarcoma
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4 Participants
n=5 Participants
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Tumor type
Extraskeletal osteosarcoma
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1 Participants
n=5 Participants
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Tumor type
Soft tissue sarcoma
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 weeks post-treatmentPopulation: Insufficient number of patients accrued for a meaningful analysis. No data collected from any participant.
Progression free rate will be determined by determining the number of patients with complete response, partial response and stable disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearToxicity will be assessed by calculating number of participants experiencing adverse events as per CTCAEv4.03 criteria
Outcome measures
| Measure |
TAK-228 Treatment
n=6 Participants
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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|---|---|
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The Rate of Toxicity of TAK-228 in This Patient Population as Per Common Terminology Criteria for Adverse Events (CTCAE)v4.03 Criteria.
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6 Participants
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SECONDARY outcome
Timeframe: upto 4 yearsPopulation: Insufficient number of patients accrued for a meaningful analysis. No data collected from any participant.
Objective response rate will be defined as patients with complete response and partial response. As per RECIST v1.1 guidelines, complete response is defined as the disappearance of all measurable lesions, and partial response is defined as \>=30% decrease in sum of diameters of target lesions compared to the baseline sum of diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: upto 4 yearsPopulation: Insufficient number of patients accrued for a meaningful analysis. No data collected from any participant.
Progression Free Survival, defined as the time from initiation of treatment until disease progression will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: upto 4 yearsPopulation: Insufficient number of patients accrued for a meaningful analysis. No data collected from any participant.
Overall Survival, defined as the time from initiation of treatment until death from any cause will be calculated.
Outcome measures
Outcome data not reported
Adverse Events
TAK-228 Treatment
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
TAK-228 Treatment
n=6 participants at risk
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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Renal and urinary disorders
Acute kidney injury
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16.7%
1/6 • Number of events 1 • 1 year
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Gastrointestinal disorders
Intractable nausea and vomiting
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16.7%
1/6 • Number of events 1 • 1 year
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Musculoskeletal and connective tissue disorders
Septic arthritis
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16.7%
1/6 • Number of events 1 • 1 year
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Other adverse events
| Measure |
TAK-228 Treatment
n=6 participants at risk
Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228
TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
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Gastrointestinal disorders
Mucositis oral
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50.0%
3/6 • Number of events 3 • 1 year
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Gastrointestinal disorders
Nausea
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50.0%
3/6 • Number of events 3 • 1 year
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Gastrointestinal disorders
Diarrhea
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33.3%
2/6 • Number of events 2 • 1 year
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Gastrointestinal disorders
Abdominal pain
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16.7%
1/6 • Number of events 1 • 1 year
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Gastrointestinal disorders
Constipation
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16.7%
1/6 • Number of events 1 • 1 year
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Gastrointestinal disorders
Taste alteration
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16.7%
1/6 • Number of events 1 • 1 year
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Gastrointestinal disorders
Vomiting
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16.7%
1/6 • Number of events 1 • 1 year
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General disorders
Fatigue
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66.7%
4/6 • Number of events 4 • 1 year
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General disorders
Pain
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33.3%
2/6 • Number of events 2 • 1 year
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General disorders
Edema
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16.7%
1/6 • Number of events 1 • 1 year
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General disorders
Fever
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16.7%
1/6 • Number of events 1 • 1 year
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Musculoskeletal and connective tissue disorders
Myalgia
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33.3%
2/6 • Number of events 2 • 1 year
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Musculoskeletal and connective tissue disorders
Back pain
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16.7%
1/6 • Number of events 1 • 1 year
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Musculoskeletal and connective tissue disorders
Generalized muscle weakness
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16.7%
1/6 • Number of events 1 • 1 year
|
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Musculoskeletal and connective tissue disorders
Right hip cramps
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16.7%
1/6 • Number of events 1 • 1 year
|
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Nervous system disorders
Dizziness
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33.3%
2/6 • Number of events 2 • 1 year
|
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Nervous system disorders
Headache
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16.7%
1/6 • Number of events 1 • 1 year
|
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Nervous system disorders
Syncope
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16.7%
1/6 • Number of events 1 • 1 year
|
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Nervous system disorders
Tremor
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16.7%
1/6 • Number of events 1 • 1 year
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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33.3%
2/6 • Number of events 2 • 1 year
|
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Respiratory, thoracic and mediastinal disorders
Cough
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16.7%
1/6 • Number of events 1 • 1 year
|
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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16.7%
1/6 • Number of events 1 • 1 year
|
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Respiratory, thoracic and mediastinal disorders
Nasal congestion
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16.7%
1/6 • Number of events 1 • 1 year
|
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Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
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16.7%
1/6 • Number of events 1 • 1 year
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Skin and subcutaneous tissue disorders
Rash maculo-papular
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50.0%
3/6 • Number of events 3 • 1 year
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Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
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33.3%
2/6 • Number of events 2 • 1 year
|
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Skin and subcutaneous tissue disorders
Dry skin
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16.7%
1/6 • Number of events 1 • 1 year
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Skin and subcutaneous tissue disorders
Pruritus
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16.7%
1/6 • Number of events 1 • 1 year
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Cardiac disorders
Cardiac disorders - Other, specify
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16.7%
1/6 • Number of events 1 • 1 year
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Cardiac disorders
Palpitations
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16.7%
1/6 • Number of events 1 • 1 year
|
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Infections and infestations
Infections and infestations - Other, specify
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33.3%
2/6 • Number of events 2 • 1 year
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Investigations
Investigations - Other, specify
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33.3%
2/6 • Number of events 2 • 1 year
|
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Investigations
Activated partial thromboplastin time prolonged
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16.7%
1/6 • Number of events 1 • 1 year
|
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Investigations
Alanine aminotransferase increased
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Weight loss
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
White blood cell decreased
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
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16.7%
1/6 • Number of events 1 • 1 year
|
|
Eye disorders
Eye disorders - Other, specify
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16.7%
1/6 • Number of events 1 • 1 year
|
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Injury, poisoning and procedural complications
Wound complication
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16.7%
1/6 • Number of events 1 • 1 year
|
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Psychiatric disorders
Depression
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16.7%
1/6 • Number of events 1 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place