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Clinical Trials/EUCTR2013-002737-38-DE
EUCTR2013-002737-38-DE
Active, not recruiting
Phase 1

A phase II trial to evaluate efficacy and safety of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 translocations - EUCROSS

niversity of Cologne0 sites30 target enrollmentFebruary 7, 2014
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ConditionsAdult patients with either firstly diagnosed or relapsed advanced adenocarcinoma of the lung harbouring ROS1 translocationMedDRA version: 20.0 Level: LLT Classification code 10025032 Term: Lung adenocarcinoma NOS System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsXalkori

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Adult patients with either firstly diagnosed or relapsed advanced adenocarcinoma of the lung harbouring ROS1 translocation
Sponsor
niversity of Cologne
Enrollment
30
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 7, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity of Cologne

Eligibility Criteria

Inclusion Criteria

  • •Patients with adenocarcinoma of the lung that is locally advanced or metastatic independent from the number of prior lines of therapy, i.e. including non\-pretreated patients (UICC stage IIIB or IV)
  • •Positive result of ROS1 translocation by central FISH\-testing is mandatory.
  • •Ability to swallow pills
  • •Age \> 18 years
  • •ECOG performance status 0 to 2
  • •Life expectancy of at least 12 weeks
  • •Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1\.1\)
  • •Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to initiation of study medication.
  • •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to screening:
  • •\- Hemoglobin \= 8\.0 g/dL

Exclusion Criteria

  • •Previous treatment with specific ALK or ROS1 inhibitors
  • •Current treatment within another therapeutic clinical trial
  • •Other history of ongoing malignancy that would potentially interfere with the interpretation of efficacy (early stage or chronic disease is allowed if not requiring active therapy or intervention and being under control)
  • •Pregnancy or breastfeeding
  • •Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole and grapefruit or grapefruit juice
  • •Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, Phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s wort
  • •Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine.
  • •Active CNS metastases, patients with brain metastasis are eligible if asymptomatic for \= 14 days before starting study medication and off corticosteroids
  • •History of or known carinomatous meningitis or leptomeningeal disease
  • •Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)

Outcomes

Primary Outcomes

Not specified

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