Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149
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|ClinicalTrials.gov Identifier: NCT03997448|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2019
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Cancer Adenocarcinoma||Drug: Pembrolizumab Drug: Abemaciclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Abemaciclib and Pembrolizumab
Abemaciclib 150mg days 1-21, and Pembrolizumab 200mg IV, Day 1
Pembrolizumab 200mg IV
Abemiciclib 150mg PO
- Progression-Free Survival [ Time Frame: 24 months ]PFS is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause).
- Progression-Free Survival Rate at 6 Months [ Time Frame: 6 Months ]PFS is defined as the percent of patients without a progression (or death event) at month 6 after treatment initiation.
- Disease Control Rate [ Time Frame: 24 Months ]DCR is defined as percent of patients with stable disease, partial response and complete response after treatment initiation per RECIST 1.1 and irRECIST.
- Overall Survival [ Time Frame: 24 Months ]OS is defined as the time of treatment initiation until death from any cause.
- Objective Response Rate [ Time Frame: 24 Months ]ORR as measured as percent of patients who achieved objective response per RECIST 1.1 and irRECIST criteria while on treatment
- Summarize Adverse Events [ Time Frame: 24 Months ]All adverse events summarized and assessed by NCI CTCAE version 5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997448
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|Univerisy of Iowa Hospital and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Rutgers Cancer Institute of NewJjersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Nataliya Uboha, MD, PhD||University of Wisconsin, Madison|