Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

NCT ID: NCT03960151

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rolapitant

Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Group Type: EXPERIMENTAL

Rolapitant

Intervention Type: DRUG

Rolapitant 180mg PO, Days 1 and 5

Palonosetron

Intervention Type: DRUG

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

Olanzapine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20 mg AM, Days 1,2 and 3

Interventions

Rolapitant

Rolapitant 180mg PO, Days 1 and 5

Intervention Type: DRUG

Palonosetron

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

Intervention Type: DRUG

Olanzapine

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

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20 mg AM, Days 1,2 and 3

Intervention Type: DRUG

Other Intervention Names

Varubi; Aloxi; Zyprexa; steroid

Eligibility Criteria

Inclusion Criteria

• Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 15 years at the time of consent.
• Must be able to take oral medications (swallow pills)
• ECOG Performance Status of 0-2 within 14 days prior to registration.
• Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen.
• Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy.
• No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
• Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve.
• Absolute Neutrophil Count (ANC) ≥ 1 K/mm3
• Hemoglobin (Hgb) ≥ 10 g/dL
• Platelets (Plt) ≥ 100 K/mm3
• Creatinine ≤ 2 mg/dL
• Bilirubin ≤ 1.5 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN
• No concurrent use of thioridazine or pimozide. No use of agents expected to induce the metabolism of rolapitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and Barbiturates.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
• Patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant.

Exclusion Criteria

• Any untreated central nervous system (CNS) metastases.
• Treatment with any investigational drug within 30 days prior to registration.
• Concurrent participation in a clinical trial which involves another investigational agent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tesaro, Inc.

INDUSTRY

Sponsor Role: collaborator

Costantine Albany

OTHER

Sponsor Role: lead

Responsible Party

Costantine Albany

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Costantine Albany, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Melvin and Bren Simon Cancer Center

Other Identifiers

HCRN GU16-254

Identifier Type: -

Identifier Source: org_study_id