Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

• Status: Withdrawn
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Costantine Albany
• Collaborator: Tesaro, Inc.
• Treatments: 8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one; BB 1101; Cisplatin; Dexamethasone; Dexamethasone acetate; Olanzapine; Palonosetron; Rolapitant

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.