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A phase 2 trial of Ramucirumab, Cisplatin, Gemcitabine in metastatic cancer, run by Eli Lilly and Company, active and no longer recruiting.
A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT02711553 by Eli Lilly and Company, with 309 participants enrolled, started 2016-05-19 and due to reach its primary completion in 2018-02-16. Interventions recorded: Ramucirumab, Merestinib, Cisplatin, Gemcitabine, Placebo Oral. Conditions listed: Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer. Results were posted on ClinicalTrials.gov in 2021; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
309 enrolled.
IQR 3.68 to 8.51; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication · IQR 4.34 to 9.79 · IQR 4.11 to 9.72
SourceIQR 8.48 to 11.76; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication · IQR 11.96 to 16.36 · IQR 11.40 to 15.31
Source95% CI 22.3 to 39.9; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication · 95% CI 11.9 to 27.3 · 95% CI 23.5 to 41.8
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS)primary | 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 106 | 6.47 months | - | - | link |
| 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 102 | 6.97 months | ||||
| Pooled Placebo | 101 | 6.64 months | ||||
| Overall Survival (OS) | 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 106 | 10.45 months | - | - | link |
| 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 102 | 14.03 months | ||||
| Pooled Placebo | 101 | 13.04 months | ||||
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 106 | 31.1% | - | - | link |
| 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine | 102 | 19.6% | ||||
| Pooled Placebo | 101 | 32.7% |
Shares Eli Lilly (incl. Loxo), Gemcitabine, Platinum agents, Cisplatin.
Shares Ramucirumab, Eli Lilly (incl. Loxo), Gemcitabine, Metastatic cancer (cancer that has spread).
Shares Ramucirumab, Eli Lilly (incl. Loxo), Anti-angiogenic therapy, Monoclonal antibodies.
Shares Ramucirumab, Eli Lilly (incl. Loxo), Anti-angiogenic therapy, Monoclonal antibodies.
Shares Ramucirumab, Anti-angiogenic therapy, Gemcitabine, Monoclonal antibodies.
Shares Ramucirumab, Eli Lilly (incl. Loxo), Anti-angiogenic therapy, Monoclonal antibodies.
Shares Ramucirumab, Anti-angiogenic therapy, Monoclonal antibodies, Cytotoxic chemotherapy.
Shares Ramucirumab, Eli Lilly (incl. Loxo), Anti-angiogenic therapy, Monoclonal antibodies.