Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

NCT03960151 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HCRN GU16-254
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• 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

  8 Days

Secondary Outcomes (9)

• Complete Response Rate: Acute Phase

  5 Days

• Complete Response Rate: Delayed Phase

  2 Days

• Frequency, intensity, and duration of nausea

  8 Days

• Frequency of vomiting or retching.

  8 Days

• Intensity of Vomiting or retching.

  8 Days

Study Arms (1)

Rolapitant

EXPERIMENTAL

Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Drug: Rolapitant; Drug: Palonosetron; Drug: Olanzapine; Drug: Dexamethasone

Interventions

Rolapitant DRUG

Rolapitant 180mg PO, Days 1 and 5

Also known as: Varubi

Rolapitant

Palonosetron DRUG

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

Also known as: Aloxi

Rolapitant

Olanzapine DRUG

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

Also known as: Zyprexa

Rolapitant

Dexamethasone DRUG

Dexamethasone 20 mg AM, Days 1,2 and 3

Also known as: steroid

Rolapitant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Costantine Albany: lead
• Tesaro, Inc.: collaborator

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

rolapitant; Palonosetron; Olanzapine; Dexamethasone; Steroids

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Costantine Albany, MD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 22, 2019
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 22, 2019

Record last verified: 2019-05