Trial Outcomes & Findings for Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP (NCT NCT00565370)

NCT ID: NCT00565370

Last Updated: 2020-01-18

Results Overview

Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 28weeks
• Results posted on: 2020-01-18

Participant Flow

Participant milestones

Measure	XP Plus Sorafenib Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP

Baseline characteristics by cohort

Measure	XP Plus Sorafenib n=21 Participants Capecitabine and cisplatin plus sorafenib
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Korea, Republic of	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 28weeks

Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

Outcome measures

Measure	XP Plus Sorafenib n=21 Participants Capecitabine and cisplatin plus sorafenib
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	3 participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	XP Plus Sorafenib n=21 Participants Capecitabine and cisplatin plus sorafenib
Progression-free Survival	10.0 Months Interval 7.4 to 13.8

SECONDARY outcome

Timeframe: 6 months

Population: Patients who had measurable lesions were included for the response rates

Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate

Outcome measures

Measure	XP Plus Sorafenib n=16 Participants Capecitabine and cisplatin plus sorafenib
Response Rate	62.8 percentage of participants Interval 38.8 to 86.2

SECONDARY outcome

Timeframe: 28 months

Outcome measures

Measure	XP Plus Sorafenib n=21 Participants Capecitabine and cisplatin plus sorafenib
Overall Survival	14.7 Months Interval 12.0 to 20.0

SECONDARY outcome

Timeframe: 28weeks

Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib

Outcome measures

Measure	XP Plus Sorafenib n=21 Participants Capecitabine and cisplatin plus sorafenib
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)	21 participants

Adverse Events

XP Plus Sorafenib

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	XP Plus Sorafenib n=21 participants at risk Capecitabine and cisplatin plus sorafenib
Gastrointestinal disorders Diarrhea	4.8% 1/21
Blood and lymphatic system disorders Febrile neutropenia	4.8% 1/21
Blood and lymphatic system disorders Deep vein thrombosis	9.5% 2/21
Gastrointestinal disorders Gastric perforation	4.8% 1/21

Other adverse events

Measure	XP Plus Sorafenib n=21 participants at risk Capecitabine and cisplatin plus sorafenib
Blood and lymphatic system disorders Neutropenia	66.7% 14/21
Blood and lymphatic system disorders Leukopenia	9.5% 2/21
Infections and infestations Febrile neutropenia	4.8% 1/21
Blood and lymphatic system disorders Anemia	9.5% 2/21
Blood and lymphatic system disorders Thrombocytopenia	19.0% 4/21
Gastrointestinal disorders Anorexia	76.2% 16/21
Gastrointestinal disorders Vomiting	57.1% 12/21
General disorders Asthenia	61.9% 13/21
Gastrointestinal disorders Stomatitis	61.9% 13/21
Gastrointestinal disorders Diarrhea	61.9% 13/21
Nervous system disorders Sensory neuropathy	85.7% 18/21
Skin and subcutaneous tissue disorders Skin rash	42.9% 9/21
Skin and subcutaneous tissue disorders Hand-foot syndrome	81.0% 17/21
Cardiac disorders Hypertension	28.6% 6/21

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: ykkang@amc.seoul.kr

Results disclosure agreements

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