Trial Outcomes & Findings for Benzoylphenylurea in Treating Patients With Advanced Solid Tumors (NCT NCT00016354)

Last Updated: 2013-03-25

Results Overview

Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays \>2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting \<5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

4 weeks (1 course of treatment for each subject)

Results posted on

2013-03-25

Participant Flow

Nineteen patients were enrolled between August 2001 and July 2004 at Johns Hopkins.

Patients were excluded if they had known brain metastases, active infections, chronic diarrhoea, malabsorption, peripheral neuropathy \>grade 1 (NCI CTC v2), pregnancy, HIV infection, or serious concurrent medical conditions.

Participant milestones

Participant milestones
Measure	Benzoylphenylurea 5 mg Benzoylphenylurea dose level of 5 mg; Dose level 1	Benzoylphenylurea 10 mg Benzoylphenylurea dose level of 10 mg; Dose level 2	Benzoylphenylurea 20 mg Benzoylphenylurea dose level of 20 mg; Dose level 3	Benzoylphenylurea 40 mg Benzoylphenylurea dose level of 40 mg; Dose level 4	Benzoylphenylurea 80 mg Benzoylphenylurea dose level of 80 mg; Dose level 5	Benzoylphenylurea 160 mg Benzoylphenylurea dose level of 160 mg; Dose level 6	Benzoylphenylurea 320 mg Benzoylphenylurea dose level of 320 mg; Dose level 7	Benzoylphenylurea Dose Level of 150 mg Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
Overall Study STARTED	1	1	1	1	1	1	6	7
Overall Study COMPLETED	1	1	1	1	1	1	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Benzoylphenylurea 5 mg Benzoylphenylurea dose level of 5 mg; Dose level 1	Benzoylphenylurea 10 mg Benzoylphenylurea dose level of 10 mg; Dose level 2	Benzoylphenylurea 20 mg Benzoylphenylurea dose level of 20 mg; Dose level 3	Benzoylphenylurea 40 mg Benzoylphenylurea dose level of 40 mg; Dose level 4	Benzoylphenylurea 80 mg Benzoylphenylurea dose level of 80 mg; Dose level 5	Benzoylphenylurea 160 mg Benzoylphenylurea dose level of 160 mg; Dose level 6	Benzoylphenylurea 320 mg Benzoylphenylurea dose level of 320 mg; Dose level 7	Benzoylphenylurea Dose Level of 150 mg Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
Overall Study Lack of Efficacy	0	0	0	0	0	0	0	1

Baseline Characteristics

Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benzoylphenylurea n=19 Participants BPU, administered over a dose range of 5-320 mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks (1 course of treatment for each subject)

Population: Participants that completed at least 1 cycle of BPU.

Outcome measures

Outcome measures
Measure	Benzoylphenylurea n=19 Participants BPU, administered over a dose range of 5-320 mg
Determine Maximum Tolerated Dose of BPU	150 milligrams (mg)

SECONDARY outcome

Timeframe: every 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome data not reported

Adverse Events

Benzoylphenylurea

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Benzoylphenylurea n=19 participants at risk BPU, administered over a dose range of 5-320 mg
Infections and infestations Neutropenic fever	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.

Other adverse events

Other adverse events
Measure	Benzoylphenylurea n=19 participants at risk BPU, administered over a dose range of 5-320 mg
Blood and lymphatic system disorders Anemia (Hemoglobin)	15.8% 3/19 • Number of events 3 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Blood and lymphatic system disorders Thrombocytopenia (Platelets)	10.5% 2/19 • Number of events 2 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
General disorders Fatigue	15.8% 3/19 • Number of events 3 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
General disorders Headache	10.5% 2/19 • Number of events 2 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Gastrointestinal disorders Diarrhea	10.5% 2/19 • Number of events 2 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Gastrointestinal disorders Nausea	15.8% 3/19 • Number of events 3 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Gastrointestinal disorders Vomiting	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Skin and subcutaneous tissue disorders Alopecia	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Respiratory, thoracic and mediastinal disorders Rhinitis	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.
Nervous system disorders Syncope	5.3% 1/19 • Number of events 1 • every 4 weeks Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the NCI CTCv2.

Additional Information

Dr. Antonio Wolff

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-614-4192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place