Trial Outcomes & Findings for Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients (NCT NCT01508117)

NCT ID: NCT01508117

Last Updated: 2017-09-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: average 1 year
• Results posted on: 2017-09-19

Participant Flow

Recruitment period 8/10/11-10/26/12

Participant milestones

Measure	Axitinib + Radiation Therapy Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

Baseline characteristics by cohort

Measure	Axitinib + Radiation Therapy n=1 Participants Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	0 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
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: average 1 year

Outcome measures

Measure

Axitinib + Radiation Therapy n=1 Participants Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Overall Survival

0.2 years

Adverse Events

Axitinib + Radiation Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure

Axitinib + Radiation Therapy n=1 participants at risk Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Infections and infestations Wound infection

100.0% 1/1 • Number of events 1 • Duration of treatment

Other adverse events

Measure

Axitinib + Radiation Therapy n=1 participants at risk Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Vascular disorders Hypertension

100.0% 1/1 • Number of events 1 • Duration of treatment

Additional Information

Alison Kastl

University of Cincinnati

Phone: 513-584-0436

Email: kastla@ucmail.uc.edu

Results disclosure agreements

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