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Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

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ClinicalTrials.gov Identifier: NCT03960151
Recruitment Status : Withdrawn (Compound was sold by funder and development ceased.)
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
Costantine Albany, Hoosier Cancer Research Network

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

Condition or disease Intervention/treatment Phase
Germ Cell Tumor Drug: Rolapitant Drug: Palonosetron Drug: Olanzapine Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rolapitant
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
Drug: Rolapitant
Rolapitant 180mg PO, Days 1 and 5
Other Name: Varubi

Drug: Palonosetron
Palonosetron 0.25 mg IV, Days 1,3, and 5.
Other Name: Aloxi

Drug: Olanzapine
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
Other Name: Zyprexa

Drug: Dexamethasone
Dexamethasone 20 mg AM, Days 1,2 and 3
Other Name: steroid




Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 8 Days ]
    Determine the complete response (CR) rate defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 8


Secondary Outcome Measures :
  1. Complete Response Rate: Acute Phase [ Time Frame: 5 Days ]
    Determine the CR rate in the acute phase (Days 1-5) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 5

  2. Complete Response Rate: Delayed Phase [ Time Frame: 2 Days ]
    Determine the CR rate in the delayed phase (Days 6-8) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 6 through Day 8

  3. Frequency, intensity, and duration of nausea [ Time Frame: 8 Days ]
    Determine the frequency, intensity and duration of nausea on Days 1-8 in Cycle 1. The frequency, intensity and duration of nausea will be captured via daily self-assessment patient logs.

  4. Frequency of vomiting or retching. [ Time Frame: 8 Days ]
    Determine the frequency, intensity and duration of vomiting or retching on Days 1-8 in Cycle 1. The frequency of vomiting and retching will be captured via daily self-assessment patient logs.

  5. Intensity of Vomiting or retching. [ Time Frame: 8 Days ]
    Determine the intensity of vomiting or retching on Days 1-8 in Cycle 1. The intensity of vomiting and retching will be captured via daily self-assessment patient logs.

  6. Duration of Vomiting or retching [ Time Frame: 8 Days ]
    Determine the duration of vomiting or retching on Days 1-8 in Cycle 1. The duration of vomiting and retching will be captured via daily self-assessment patient logs.

  7. Rate of no nausea [ Time Frame: 8 Days ]
    Determine the rate of no nausea defined as < 5mm on a 0-100mm visual analog scale (VAS) on Days 1-5 and Days 6-8 on Cycle 1

  8. Use of rescue medications [ Time Frame: 8 Days ]
    Describe the use of rescue medications as defined in the protocol

  9. Assess adverse events of regimen using CTCAE v4. [ Time Frame: 8 Days ]
    Safety and toxicity will be assessed using CTCAE v4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960151


Sponsors and Collaborators
Costantine Albany
Tesaro, Inc.
Investigators
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Principal Investigator: Costantine Albany, MD Indiana University Melvin and Bren Simon Cancer Center

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Responsible Party: Costantine Albany, Sponsor Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT03960151     History of Changes
Other Study ID Numbers: HCRN GU16-254
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Dexamethasone
Dexamethasone acetate
Cisplatin
Olanzapine
Palonosetron
BB 1101
8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors