Trial record 2 of 12 for:
rolapitant
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03960151 |
Recruitment Status :
Withdrawn
(Compound was sold by funder and development ceased.)
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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Sponsor:
Costantine Albany
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
Costantine Albany, Hoosier Cancer Research Network
Tracking Information | |||||||
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First Submitted Date ICMJE | March 26, 2018 | ||||||
First Posted Date ICMJE | May 22, 2019 | ||||||
Last Update Posted Date | May 22, 2019 | ||||||
Estimated Study Start Date ICMJE | May 2018 | ||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Complete Response Rate [ Time Frame: 8 Days ] Determine the complete response (CR) rate defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 8
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
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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 | Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy | ||||||
Official Title ICMJE | Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy. | ||||||
Brief Summary | Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Germ Cell Tumor | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Rolapitant
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE |
0 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 2022 | ||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03960151 | ||||||
Other Study ID Numbers ICMJE | HCRN GU16-254 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Costantine Albany, Hoosier Cancer Research Network | ||||||
Study Sponsor ICMJE | Costantine Albany | ||||||
Collaborators ICMJE | Tesaro, Inc. | ||||||
Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |