Trial Outcomes & Findings for Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric Cancer (NCT NCT02726399)

Last Updated: 2020-01-21

Results Overview

as measured from the start of the ramucirumab and trastuzumab to the date of either documentation of disease progression on chemotherapy with trastuzumab and ramucirumab or death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2020-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Ramucirumab With Trastuzumab and Capecitabine/Cisplatin This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days. Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Ramucirumab With Trastuzumab and Capecitabine/Cisplatin This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days. Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days
Overall Study Participant Non-Compliance	1
Overall Study Adverse Event	2
Overall Study Progression of disease	4

Baseline Characteristics

Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramucirumab With Trastuzumab and Capecitabine/Cisplatin n=7 Participants This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days. Ramucirumab: Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days Trastuzumab: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days Capecitabine: Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period Cisplatin: Cisplatin 80mg/m2 administered as an IV infusion every 21 days
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	6 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	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Data were not collected

as measured from the start of the ramucirumab and trastuzumab to the date of either documentation of disease progression on chemotherapy with trastuzumab and ramucirumab or death.

Outcome measures

Outcome data not reported

Adverse Events

Ramucirumab With Trastuzumab and Capecitabine/Cisplatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yelena Janjigian, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place