Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophagus Cancer, Adenocarcinoma Stomach Cancer, Adenocarcinoma | Drug: Rucaparib Drug: Ramucirumab Drug: Nivolumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 61 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Phase 1 - Safety Lead In - Enroll 6-9 molecularly unselected participants to determine the safety of the triplet combination of Rucaparib plus Ramucirumab and Nivolumab. One level dose de-escalation of Rucaparib will be planned based on dose limiting toxicity (DLT) signal of the first 6 participants run in phase. Phase 2 - Parallel - Enroll 52 participants (26 in each cohort), open label, two treatment cohorts design evaluating Rucaparib plus Ramucirumab with or without Nivolumab. 50 percent (%) of participants enrollment to each treatment cohort will represent molecularly unselected population and the remaining 50% will be selected based on integrated screening tumor Homologous Recombination Deficiency (HRD) gene panel. The primary objective is efficacy by measuring the Overall Response Rate (ORR). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Trial of Rucaparib in Combination With Ramucirumab With or Without Nivolumab in Previously Treated Patients With Advanced Gastric and Esophageal Adenocarcinoma (RiME) |
Actual Study Start Date : | January 9, 2020 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Safety Lead In
|
Drug: Rucaparib
Rucaparib tablet
Other Name: Rubraca
Drug: Ramucirumab Ramucirumab intravenous solution
Other Name: Cyramza
Drug: Nivolumab Nivolumab intravenous solution
Other Names:
|
Experimental: Cohort A
|
Drug: Rucaparib
Rucaparib tablet
Other Name: Rubraca
Drug: Ramucirumab Ramucirumab intravenous solution
Other Name: Cyramza
Drug: Nivolumab Nivolumab intravenous solution
Other Names:
|
Active Comparator: Cohort B
|
Drug: Rucaparib
Rucaparib tablet
Other Name: Rubraca
Drug: Ramucirumab Ramucirumab intravenous solution
Other Name: Cyramza
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of another primary malignancy except for:
Contact: KUCC Navigation | 913-588-3671 | kucc_navigation@kumc.edu |
United States, Illinois | |
University of Chicago Medical Center | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Jennifer Mitchell 773-702-0405 jmitchel@medicine.bsd.uchicago.edu | |
Contact: Tamika Harrs 773-702-4367 tharris@bsd.uchicago.edu | |
Principal Investigator: Daniel Catenacci, MD | |
United States, Kansas | |
KU Cancer Center | Recruiting |
Fairway, Kansas, United States, 66205 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
University of Kansas Cancer Center - CRC | Recruiting |
Fairway, Kansas, United States, 66205 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
Hays Medical Center | Recruiting |
Hays, Kansas, United States, 67601 | |
Contact: Josette Klaus, RN 785-623-5761 josette.klaus@haysmed.com | |
Contact: Shawn Mulkey, RN 785-623-5774 shawn.mulkey@hays.com | |
University of Kansas Cancer Center - West | Recruiting |
Kansas City, Kansas, United States, 66112 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
The University of Kansas Cancer Center, Westwood Campus | Recruiting |
Kansas City, Kansas, United States, 66205 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
Olathe Medical Center | Recruiting |
Olathe, Kansas, United States, 66061 | |
Contact: Jeni Wakefield, RN 913-791-3500 ext 4096 | |
University of Kansas Cancer Center - Overland Park | Recruiting |
Overland Park, Kansas, United States, 66210 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
Via Christi Cancer Center | Recruiting |
Pittsburg, Kansas, United States, 66762 | |
Contact: Melinda Adair, RN 620-235-7906 | |
Salina Regional Health | Recruiting |
Salina, Kansas, United States, 67401 | |
Contact: Melanie Leepers, RN 785-452-7038 | |
St. Francis Comprehensive Cancer Center | Recruiting |
Topeka, Kansas, United States, 66606 | |
Contact: Michelle Kipp 785-270-5198 | |
United States, Missouri | |
Truman Medical Center | Recruiting |
Kansas City, Missouri, United States, 64108 | |
University of Kansas Cancer Center - North | Recruiting |
Kansas City, Missouri, United States, 64154 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu | |
University of Kansas Cancer Center - Lee's Summit | Recruiting |
Lee's Summit, Missouri, United States, 64064 | |
Contact: KUCC Navigation 913-588-3671 kucc_navigation@kumc.edu |
Principal Investigator: | Anwaar Saeed, MD | Kansas University Cancer Center |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 19, 2019 | ||||
First Posted Date ICMJE | June 21, 2019 | ||||
Last Update Posted Date | November 10, 2020 | ||||
Actual Study Start Date ICMJE | January 9, 2020 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma | ||||
Official Title ICMJE | A Phase I/II Trial of Rucaparib in Combination With Ramucirumab With or Without Nivolumab in Previously Treated Patients With Advanced Gastric and Esophageal Adenocarcinoma (RiME) | ||||
Brief Summary | The study population is advanced gastric, gastroesophageal, and esophageal adenocarcinoma participants who have failed upfront standard of care chemotherapy. The goal is to demonstrate that Rucaparib plus Ramucirumab with or without Nivolumab has a higher response rate than what has been reported for Ramucirumab in previously treated patients. Trial will be a phase 1/2 trial. The Phase 1 portion will determine the recommended Phase 2 treatment dose for the combination of Rucaparib plus Ramucirumab and Nivolumab and enroll approximately 6-9 participants. The Phase 2 portion of the study will involve 52 participants allocated between two treatment groups comparing Rucaparib plus Ramucirumab with or without Nivolumab. The participants will be selected based on the results of a screening HRD gene panel. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: Phase 1 - Safety Lead In - Enroll 6-9 molecularly unselected participants to determine the safety of the triplet combination of Rucaparib plus Ramucirumab and Nivolumab. One level dose de-escalation of Rucaparib will be planned based on dose limiting toxicity (DLT) signal of the first 6 participants run in phase. Phase 2 - Parallel - Enroll 52 participants (26 in each cohort), open label, two treatment cohorts design evaluating Rucaparib plus Ramucirumab with or without Nivolumab. 50 percent (%) of participants enrollment to each treatment cohort will represent molecularly unselected population and the remaining 50% will be selected based on integrated screening tumor Homologous Recombination Deficiency (HRD) gene panel. The primary objective is efficacy by measuring the Overall Response Rate (ORR). Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
61 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2024 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03995017 | ||||
Other Study ID Numbers ICMJE | IIT-2018-RucaRamNivo | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Anwaar Saeed, University of Kansas Medical Center | ||||
Study Sponsor ICMJE | Anwaar Saeed | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
PRS Account | University of Kansas Medical Center | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |