An Open-label, Multicenter Phase Ib/II Study of Ramucirumab in Combination With Trastuzumab and Weekly Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer
Sponsor study identifier
interventional
50
1 country
1
Study Start
February 13, 2018
Actual (reported)Primary Completion
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Human epidermal growth factor receptor 2 (HER2) is overexpressed or amplified in 10-20% of gastric or gastroesophageal junction cancer. Trastuzumab combined with fluorouracil and platinum has been established as first-line treatment for patients with HER2-positive gastric cancer. The role of trastuzumab in second-line treatment for HER2-positive gastric cancer has not yet been addressed. Here, we evaluated the safety and efficacy of adding trastuzumab to ramucirumab and paclitaxel combination as a second-line treatment in HER2-positive gastric cancer progressed after trastuzumab-containing chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2018
Actual (reported)May 9, 2021
Actual (reported)May 17, 2021
Actual (reported)September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Phase 1b: Maximum tolerated dose of trastuzumab, ramucirumab, and paclitaxel combination treatment in patients with HER2-positive gastric cancer
Phase 1b: During the first 4 weeks of treatment
Phase 2: Progression-free survival in patients with HER2-positive gastric cancer receiving trastuzumab, ramucirumab, and paclitaxel combination treatment
Phase 2: At 24 weeks after start of treatment
Overall survival
through study completion, an average of 2 years
Objective response rate according to RECIST 1.1
through study completion, an average of 2 years
Disease control rate according to RECIST 1.1
through study completion, an average of 2 years
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE v4.02
Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
(Phase Ib part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel 80 or 70 mg/m2 IV (according to dose level) (Phase II part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel at RP2D (80 or 70 mg/m2 IV)
For both Phase Ib and II: Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg on Days 1, 8, 15 and 22, and ramucirumab 8 mg/kg on Days 1 and 15, as well as paclitaxel will be administered intravenously in a 4-week cycle (every 28 days) For Phase Ib, Paclitaxel 80 or 70 mg/m2 (according to dose level) will be administered on Days 1, 8, 15 For Phase II, paclitaxel at RP2D (80 or 70 mg/m2) will be administered on Days 1, 8, 15 of each cycle
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Trastuzumab + Ramucirumab + Paclitaxel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordYonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, 03722, South Korea
Kim CG, Jung M, Kim HS, Lee CK, Jeung HC, Koo DH, Bae WK, Zang DY, Kim BJ, Kim H, Yun UJ, Che J, Park S, Kim TS, Kwon WS, Park J, Cho SW, Nam CM, Chung HC, Rha SY. Trastuzumab Combined With Ramucirumab and Paclitaxel in Patients With Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Advanced Gastric or Gastroesophageal Junction Cancer. J Clin Oncol. 2023 Sep 20;41(27):4394-4405. doi: 10.1200/JCO.22.02122. Epub 2023 Jun 26.
Sun Young RHA, MD, PhD
Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine
50 participants (actual enrollment reported by the registry).
First Submitted
May 9, 2021
First Posted
May 17, 2021
Study Start
February 13, 2018
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 21, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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