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Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Primary Purpose

Germ Cell Tumor

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Rolapitant

Palonosetron

Olanzapine

Dexamethasone

About this trial

This is an interventional treatment trial for Germ Cell Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rolapitant

Arm Description

Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Outcomes

Primary Outcome Measures

Complete Response Rate

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

Complete Response Rate: Acute Phase

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

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

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.

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.

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

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

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

Describe the use of rescue medications as defined in the protocol

Assess adverse events of regimen using CTCAE v4.

Safety and toxicity will be assessed using CTCAE v4

Full Information

NCT ID

NCT03960151

First Posted

March 26, 2018

Last Updated

May 21, 2019

Sponsor

Costantine Albany

Collaborators

Tesaro, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03960151

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Compound was sold by funder and development ceased.

Study Start Date

May 2018 (Anticipated)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Costantine Albany

Collaborators

Tesaro, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Germ Cell Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rolapitant

Arm Type

Experimental

Arm Description

Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Rolapitant

Other Intervention Name(s)

Varubi

Intervention Description

Rolapitant 180mg PO, Days 1 and 5

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Other Intervention Name(s)

Aloxi

Intervention Description

Palonosetron 0.25 mg IV, Days 1,3, and 5.

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

steroid

Intervention Description

Dexamethasone 20 mg AM, Days 1,2 and 3

Primary Outcome Measure Information:

Title

Complete Response Rate

Description

Time Frame

8 Days

Secondary Outcome Measure Information:

Title

Complete Response Rate: Acute Phase

Description

Time Frame

5 Days

Title

Complete Response Rate: Delayed Phase

Description

Time Frame

2 Days

Title

Frequency, intensity, and duration of nausea

Description

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.

Time Frame

8 Days

Title

Frequency of vomiting or retching.

Description

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.

Time Frame

8 Days

Title

Intensity of Vomiting or retching.

Description

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.

Time Frame

8 Days

Title

Duration of Vomiting or retching

Description

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.

Time Frame

8 Days

Title

Rate of no nausea

Description

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

Time Frame

8 Days

Title

Use of rescue medications

Description

Describe the use of rescue medications as defined in the protocol

Time Frame

8 Days

Title

Assess adverse events of regimen using CTCAE v4.

Description

Safety and toxicity will be assessed using CTCAE v4

Time Frame

8 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Costantine Albany, MD

Organizational Affiliation

Indiana University Melvin and Bren Simon Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

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