Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: March 26, 2018
• First Posted Date: May 22, 2019
• Last Update Posted Date: May 22, 2019
• Estimated Study Start Date: May 2018
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Germ Cell Tumor

Intervention

• 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

Experimental: Rolapitant

Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Interventions:

• Drug: Rolapitant
• Drug: Palonosetron
• Drug: Olanzapine
• Drug: Dexamethasone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 21, 2019): 0
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: March 2022
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03960151
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Costantine Albany, Hoosier Cancer Research Network
• Study Sponsor: Costantine Albany
• Collaborators: Tesaro, Inc.

Investigators

• Principal Investigator: Costantine Albany, MD; Indiana University Melvin and Bren Simon Cancer Center

• PRS Account: Hoosier Cancer Research Network
• Verification Date: May 2019