Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Costantine Albany

Status and phase

Withdrawn

Phase 2

Conditions

Germ Cell Tumor

Treatments

Drug: Dexamethasone

Drug: Palonosetron

Drug: Rolapitant

Drug: Olanzapine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03960151

HCRN GU16-254

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.