Trial Outcomes & Findings for TRC105 for Recurrent Glioblastoma (NCT NCT01778530)

NCT ID: NCT01778530

Last Updated: 2015-10-07

Results Overview

Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is \>/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a \>/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 14 months
• Results posted on: 2015-10-07

Participant Flow

Participant milestones

Measure	TRC105 for Recurrent Glioblastoma TRC105: Intravenous infusion.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	TRC105 for Recurrent Glioblastoma TRC105: Intravenous infusion.
Overall Study Progression on study	1
Overall Study Adverse event/side effect	1

Baseline Characteristics

TRC105 for Recurrent Glioblastoma

Baseline characteristics by cohort

Measure	TRC105 for Recurrent Glioblastoma n=2 Participants TRC105: Intravenous infusion.
Age, Continuous	48 years STANDARD_DEVIATION 7.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 months

Population: This outcome measure was not met due to termination of the study for poor accrual.

Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 months, 28 days

Here is the number of participants with adverse events. For details, see the adverse event module.

Outcome measures

Measure	TRC105 for Recurrent Glioblastoma n=2 Participants TRC105: Intravenous infusion.
Number of Participants With Adverse Events	1 participants

Adverse Events

TRC105 for Recurrent Glioblastoma

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	TRC105 for Recurrent Glioblastoma n=2 participants at risk TRC105: Intravenous infusion.
General disorders Infusion related reaction	50.0% 1/2 • Number of events 1

Other adverse events

Measure	TRC105 for Recurrent Glioblastoma n=2 participants at risk TRC105: Intravenous infusion.
General disorders Fatigue	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders Generalized muscle weakness	50.0% 1/2 • Number of events 1
Nervous system disorders Headache	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • Number of events 1
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 1
Nervous system disorders Seizure	50.0% 1/2 • Number of events 2

Additional Information

Dr. Joohee Sul

National Cancer Institute

Phone: 301-402-6298

Email: Joohee_Sul@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place