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Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

NCT03960151 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-22

No results posted yet for this study

Summary

Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy

Conditions

  • Germ Cell Tumor

Interventions

DRUG

Rolapitant

Rolapitant 180mg PO, Days 1 and 5

DRUG

Palonosetron

Palonosetron 0.25 mg IV, Days 1,3, and 5.

DRUG

Olanzapine

Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8

DRUG

Dexamethasone

Dexamethasone 20 mg AM, Days 1,2 and 3

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • Costantine Albany

    lead OTHER

Principal Investigators

  • Costantine Albany, MD · Indiana University Melvin and Bren Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2021-05-31
Completion
2022-03-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960151 on ClinicalTrials.gov