Trial Outcomes & Findings for Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma (NCT NCT01861301)
NCT ID: NCT01861301
Last Updated: 2016-10-24
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
TERMINATED
PHASE2
18 participants
Up to 1 year
2016-10-24
Participant Flow
Participant milestones
| Measure |
Treatment (Tivantinib)
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Treatment (Tivantinib)
n=18 Participants
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
66.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Note: Study terminated for futility due to insufficient number of objective responders in first stage.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Tivantinib)
n=18 Participants
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
0 percentage of participants
Interval 0.0 to 18.5
|
SECONDARY outcome
Timeframe: Up to 2 yearsGrade 3 or higher AE of any type, regardless of attribution.
Outcome measures
| Measure |
Treatment (Tivantinib)
n=18 Participants
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events, Graded Per NCI CTCAE Version 4
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsAnalyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Tivantinib)
n=18 Participants
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
12.2 Months
Interval 7.1 to 22.2
|
SECONDARY outcome
Timeframe: Up to 2 yearsTime to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Tivantinib)
n=18 Participants
Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
1.9 Months
Interval 1.8 to 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 1 yearFisher's exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar's test will be used for binary markers.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 1 yearWill be evaluated by Spearman's rank correlation coefficient.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 1 yearWill be evaluated using the Cox regression model.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Tivantinib)
Serious adverse events
| Measure |
Treatment (Tivantinib)
n=18 participants at risk
Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.6%
1/18
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18
|
Other adverse events
| Measure |
Treatment (Tivantinib)
n=18 participants at risk
Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18
|
|
Investigations
Alkaline phosphaase increased
|
11.1%
2/18
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
9/18
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
3/18
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18
|
|
Investigations
Aspartate aminotransferase increase
|
27.8%
5/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18
|
|
Eye disorders
Blurred vision
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
2/18
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18
|
|
Investigations
Creatinine increased
|
22.2%
4/18
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.9%
7/18
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Edema
|
5.6%
1/18
|
|
General disorders
Fatigue
|
77.8%
14/18
|
|
General disorders
Fever
|
16.7%
3/18
|
|
General disorders
Flu like symptoms
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18
|
|
General disorders
Jitteriness
|
5.6%
1/18
|
|
Nervous system disorders
Headache
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.2%
4/18
|
|
Vascular disorders
Hypertension
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.8%
5/18
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
3/18
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
3/18
|
|
Vascular disorders
Hypotension
|
5.6%
1/18
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18
|
|
Gastrointestinal disorders
Nausea/vomiting
|
16.7%
3/18
|
|
Nervous system disorders
Neuropathy-sensory
|
11.1%
2/18
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18
|
|
General disorders
Pain
|
22.2%
4/18
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18
|
|
Investigations
Platelet count decreased
|
5.6%
1/18
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
3/18
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
2/18
|
|
Reproductive system and breast disorders
Testicular pain
|
5.6%
1/18
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18
|
|
Investigations
White blood cell decreased
|
22.2%
4/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60