Trial Outcomes & Findings for PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma (NCT NCT00686842)

NCT ID: NCT00686842

Last Updated: 2018-06-06

Results Overview

Patients who experienced an adverse event of grade 3 or greater

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: All study visits
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	VEGF Inhibitor PTC299 Single arm study - all subjects received PTC299
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma

Baseline characteristics by cohort

Measure	VEGF Inhibitor PTC299 n=17 Participants Single arm study - all subjects received PTC299
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.7 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: All study visits

Patients who experienced an adverse event of grade 3 or greater

Outcome measures

Measure	VEGF Inhibitor PTC299 n=17 Participants Single arm study - all subjects received PTC299
Safety and Toxicity of Anti-VEGF Small Molecule PTC299	7 participants

PRIMARY outcome

Timeframe: After each group of 3 subjects completes cycle 1 of treatment

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After each 28-day cycle of treatment and at discontinuation of therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 15, 28, 57

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening and day 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening and day 28

Outcome measures

Outcome data not reported

Adverse Events

VEGF Inhibitor PTC299

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	VEGF Inhibitor PTC299 n=17 participants at risk Single arm study - all subjects received PTC299
General disorders Sudden death	5.9% 1/17 • Number of events 1
Renal and urinary disorders Renal and urinary disorder	5.9% 1/17 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1

Other adverse events

Measure	VEGF Inhibitor PTC299 n=17 participants at risk Single arm study - all subjects received PTC299
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • Number of events 2
General disorders Acidosis	11.8% 2/17 • Number of events 2
Metabolism and nutrition disorders alanine aminotransferase increases	11.8% 2/17 • Number of events 4
Skin and subcutaneous tissue disorders alopecia	11.8% 2/17 • Number of events 2
Blood and lymphatic system disorders Anemia	11.8% 2/17 • Number of events 2
Immune system disorders Arthralgia	11.8% 2/17 • Number of events 2
Investigations Blood bilirubin increased	17.6% 3/17 • Number of events 3
Infections and infestations Cholesterol high	23.5% 4/17 • Number of events 6
Gastrointestinal disorders Constipation	11.8% 2/17 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough	11.8% 2/17 • Number of events 2
Investigations Creatinine increased	17.6% 3/17 • Number of events 3
Gastrointestinal disorders Diarrhea	23.5% 4/17 • Number of events 5
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 2
General disorders Edema face	11.8% 2/17 • Number of events 2
General disorders Edema limbs	17.6% 3/17 • Number of events 3
General disorders Fatigue	29.4% 5/17 • Number of events 6
Nervous system disorders Headache	11.8% 2/17 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	29.4% 5/17 • Number of events 8
Metabolism and nutrition disorders Hypertriglyceridemia	29.4% 5/17 • Number of events 6
Metabolism and nutrition disorders Hypoalbuminemia	17.6% 3/17 • Number of events 4
Metabolism and nutrition disorders Hypocalcemia	11.8% 2/17 • Number of events 5
Metabolism and nutrition disorders Hyponatremia	11.8% 2/17 • Number of events 2
Metabolism and nutrition disorders Hypophosphatemia	11.8% 2/17 • Number of events 3
Gastrointestinal disorders Nausea	41.2% 7/17 • Number of events 10
Blood and lymphatic system disorders Neutrophil count decreases	11.8% 2/17 • Number of events 2
Musculoskeletal and connective tissue disorders Pain	29.4% 5/17 • Number of events 6
Nervous system disorders Peripheral sensory neuropathy	11.8% 2/17 • Number of events 2
Renal and urinary disorders Proteinuria	17.6% 3/17 • Number of events 4
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	11.8% 2/17 • Number of events 2
Infections and infestations Skin infection	17.6% 3/17 • Number of events 4
Gastrointestinal disorders Vomiting	17.6% 3/17 • Number of events 5

Additional Information

Susan Krown, MD, Protocol Chair

AMC

Phone: 301-251-1161

Email: amcpm@emmes.com

Results disclosure agreements

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