Clinical trial · Interventional
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.
NCT03960151CI-TRIAL-00038749withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Compound was sold by funder and development ceased.
Summary
Brief summary (as posted)
Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Olanzapine | Drug | — | UNRESOLVED |
| Palonosetron | Drug | — | UNRESOLVED |
| Rolapitant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rolapitant
- description
- Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
- interventionNames
- Drug: Rolapitant
- Drug: Palonosetron
- Drug: Olanzapine
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- 8 Days
- description
- 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 outcomes (9)
- measure
- Complete Response Rate: Acute Phase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.