Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

C

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Withdrawn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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Rolapitant
Experimental group
Description:
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
Treatment:
Drug: Olanzapine
Drug: Palonosetron
Drug: Rolapitant
Drug: Dexamethasone

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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