Trial Outcomes & Findings for TPI 287 in Patients With Recurrent Glioblastoma Multiforme (NCT NCT01113463)
NCT ID: NCT01113463
Last Updated: 2016-10-31
Results Overview
PFS defined as number of participants alive without documented evidence of disease progression ("progression free") at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
TERMINATED
PHASE2
17 participants
6 months (following nine 21-day cycles)
2016-10-31
Participant Flow
Recruitment Period: April 27, 2010 to August 09, 2011. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
The study stopped enrollment of participants since a competing study with the drug combination was planned.
Participant milestones
| Measure |
TPI 287
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
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Overall Study
STARTED
|
17
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Overall Study
COMPLETED
|
12
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
TPI 287
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
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Overall Study
Physician Decision
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5
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Baseline Characteristics
TPI 287 in Patients With Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
TPI 287
n=17 Participants
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
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Age, Continuous
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61 years
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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17 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 months (following nine 21-day cycles)Population: Intent to treat population included all eligible subjects who received at least one dose of study drug.
PFS defined as number of participants alive without documented evidence of disease progression ("progression free") at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
TPI 287
n=17 Participants
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
|
Progression-Free Survival (PFS) at 6 Months
|
0 participants
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SECONDARY outcome
Timeframe: Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)Population: Intent to treat population included all eligible subjects who received at least one dose of study drug.
Complete Response (CR): Complete disappearance all measurable \& evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): \>/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented \& one or more measurable or evaluable sites have not been assessed.
Outcome measures
| Measure |
TPI 287
n=17 Participants
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
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Number of Participants by Response Criteria
Complete Response (CR)
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0 participants
|
|
Number of Participants by Response Criteria
Partial Response (PR)
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0 participants
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|
Number of Participants by Response Criteria
Stable/No Response
|
6 participants
|
|
Number of Participants by Response Criteria
Progression
|
10 participants
|
|
Number of Participants by Response Criteria
Unknown
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1 participants
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Adverse Events
TPI 287
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TPI 287
n=17 participants at risk
TPI 287: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
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|---|---|
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Metabolism and nutrition disorders
Alkaline Phosphatase Increased
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
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|
Immune system disorders
Allergic Rhinitis
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Change in SGPT/SGOT
|
23.5%
4/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
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|
Nervous system disorders
Ataxia
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Confusion
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Creatinine increase
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
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General disorders
Fatigue
|
47.1%
8/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
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Musculoskeletal and connective tissue disorders
Gait/Walking Difficulty
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Heartburn
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Hemoglobin Changes
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Cardiac disorders
Hypertension
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Infections and infestations
Infection with Normal Anc (Lung - Pneumonia)
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Infections and infestations
Infection with Normal ANC (Urinary Tract Nos)
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
General disorders
Insomnia
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Leukocytes, low
|
47.1%
8/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.6%
3/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Memory Impairment
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Altered Mental Status
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Mucositis
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness (Whole Body/Generalized)
|
29.4%
5/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
35.3%
6/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
General disorders
Pain
|
29.4%
5/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Petechiae
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
17.6%
3/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Psychosis
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
General disorders
Rigors/Chills
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Sensory Loss
|
23.5%
4/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Nervous system disorders
Speech Impairment
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Adverse event reporting from Day 1, cycle 1 to 30 days after last dose of treatment drug. Study period was May 26, 2010 to June 30, 2011.
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Additional Information
Charles A. Conrad, MD / Professor, Neuro Oncology
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place