Table 2.
Ongoing studies of ramucirumab in advanced gastric and gastroesophageal cancers
| ClinicalTrials.gov identifier | Study status | Hypothesis | Study type | Estimated enrollment | Estimated completion date | Treatment regimen | Current primary outcome measures | Current secondary outcome measures |
|---|---|---|---|---|---|---|---|---|
| NCT01983878 | Ongoing but not recruiting participants | A study of ramucirumab in treating Japanese participants with metastatic gastric or gastroesophageal junction cancer, following disease progression on first-line platinum-containing or -containing combination therapy in Japanese patients | Phase II interventional, single arm, open-label trial | 33 Japanese participants | September 2015 | Ramucirumab 8 mg/kg administered IV once every 2 weeks | PFS rate at 12 weeks | PFS (estimated up to 12 months) ORR DCR OS Number of participants with anti-ramucirumab antibodies |
| NCT02314117 | Currently recruiting participants | To evaluate the effectiveness of ramucirumab in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone as first-line therapy in patients with metastatic gastric or gastroesophageal junction adenocarcinoma (RAINFALL) |
Randomized, double- blind, placebo-controlled phase III study | 616 | April 2018 | 8 mg/kg ramucirumab given IV on days 1 and 8 in combination with 80 mg/m2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1,000 mg/m2 capecitabine given orally twice a day on days 1 through 14. Participants who are unable to take capecitabine will be given 800 mg/m2/day 5-fluorouracil (5-FU) IV on days 1–5 of each 21-day cycle |
PFS | OS ORR DCR TTP DoR Time to deterioration in ECOG PS QoL Number of participants with anti-ramucirumab antibodies |
| NCT02082210 | Currently recruiting participants | Part A: dose-ranging study Part B: safety/efficacy study to find a recommended schedule and dose range for LY2875358 when given with ramucirumab that may be safely given to participants with advanced and/or metastatic cancer of any of the following types: gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, hepatocellular cancer, renal cell carcinoma, or non-small cell lung cancer |
Phase 1b/II doseescalating and safety open-label study | 70 | December 2015 | Experimental: LY2875358 + ramucirumab (Part A) Part A: dose escalation of LY2875358 administered IV on days 1 and 15 every 28-day cycle in combination with a fixed dose of ramucirumab administered IV on days 1 and 15 of every 28-day cycle Experimental: LY2875358 + ramucirumab (Part B) Part B: recommended LY2875358 dose from Part A to be administered IV on days 1 and 15 of every 28-day cycle in combination with a fixed dose of ramucirumab administered IV on days 1 and 15 of every 28-day cycle |
Part A: number of participants who experienced DLTs Part B: ORR |
DCR PFS Number of participants with anti-ramucirumab and anti-LY2875358 antibodies |
| NCT02317991 | Not yet open for participant recruitment | To determine whether nab-paclitaxel and ramucirumab are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy | Phase II, single-arm, open-label trial | 65 | December 2017 | All patients will receive 125 mg/m2 of nab-paclitaxel V on days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest) Patients will receive ramucirumab 8 mg/kg IV in combination with nab-paclitaxel on days 1 and 15 of the 28-day cycle |
PFS | ORR OS TTP |
Abbreviations: 5-FU, fluorouracil 5-FU; DCR, disease control rate; DLTs, dose-limiting toxicities; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; IV, intravenously; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PS, performance status; QoL, quality of life; TTP, time to progression.