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Trial record 2 of 12 for:    rolapitant

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Recruitment Status : Withdrawn (Compound was sold by funder and development ceased.)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

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Estimated Study Start Date  ICMJE May 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Use of rescue medications [ Time Frame: 8 Days ]
    Describe the use of rescue medications as defined in the protocol
  • Assess adverse events of regimen using CTCAE v4. [ Time Frame: 8 Days ]
    Safety and toxicity will be assessed using CTCAE v4
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Official Title  ICMJE Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.
Brief Summary Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Germ Cell Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Rolapitant
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
Interventions:
  • Drug: Rolapitant
  • Drug: Palonosetron
  • Drug: Olanzapine
  • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960151
Other Study ID Numbers  ICMJE HCRN GU16-254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Costantine Albany, Hoosier Cancer Research Network
Study Sponsor  ICMJE Costantine Albany
Collaborators  ICMJE Tesaro, Inc.
Investigators  ICMJE
Principal Investigator: Costantine Albany, MD Indiana University Melvin and Bren Simon Cancer Center
PRS Account Hoosier Cancer Research Network
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP