WithdrawnNCT03960151Updated May 22, 2019

Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

A Phase 2 interventional study of Rolapitant and Palonosetron in Germ Cell Tumor, sponsored by Costantine Albany. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-22.

Sponsored by Costantine Albany · Phase 2, Interventional, and Treatment

Why this study was withdrawn

Compound was sold by funder and development ceased.

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Germ Cell Tumor

Browse trials for

Neoplasms, Germ Cell and Embryonal 295

In context

Neoplasms, Germ Cell and Embryonal

295 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.

Browse Neoplasms, Germ Cell and Embryonal studies →

Lead sponsor

Costantine Albany is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Rolapitant
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
Drug: Rolapitant · Drug: Palonosetron · Drug: Olanzapine · Drug: Dexamethasone

Interventions

DrugRolapitant
Rolapitant 180mg PO, Days 1 and 5
Also known as: Varubi
DrugPalonosetron
Palonosetron 0.25 mg IV, Days 1,3, and 5.
Also known as: Aloxi
DrugOlanzapine
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
Also known as: Zyprexa
DrugDexamethasone
Dexamethasone 20 mg AM, Days 1,2 and 3
Also known as: steroid

What researchers measure

Primary outcomes

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
Time frame: 8 Days

Secondary outcomes

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
Time frame: 5 Days
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
Time frame: 2 Days
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.
Time frame: 8 Days
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.
Time frame: 8 Days
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.
Time frame: 8 Days
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.
Time frame: 8 Days
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
Time frame: 8 Days
Use of rescue medications
Describe the use of rescue medications as defined in the protocol
Time frame: 8 Days
Assess adverse events of regimen using CTCAE v4.
Safety and toxicity will be assessed using CTCAE v4
Time frame: 8 Days

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03960151
Lead sponsor: Costantine Albany
Collaborators: Tesaro, Inc.
Responsible party: Costantine Albany (Sponsor Investigator, Hoosier Cancer Research Network) — Sponsor-investigator
First posted: May 22, 2019
Start date: May 2018 (estimated)
Primary completion: May 2021 (estimated)
Completion: Mar 2022 (estimated)
Last update: May 22, 2019

Study contacts

Costantine Albany, MD

principal investigator · Indiana University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Rolapitant · Palonosetron · Olanzapine · Dexamethasone

Other studies in this condition

Neoplasms, Germ Cell and Embryonal →

Other studies from this sponsor

Costantine Albany

Start the discussion