EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer

NCT02183870

Last updated date
Study Location
Thoraxklinik Heidelberg
Heidelberg, Baden-Würtemberg, 69126, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer, Adenocarcinoma, NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 for ROS1 translocation by central FISH-testing

- 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

- Absolute neutrophil count (ANC) ≥ 1,000 /mm3

- Platelet count ≥ 50 000/µL

- Total bilirubin ≤ 2 x upper limit of normal (ULN)

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) ≤ 2,5 x ULN or ≤ 5 x ULN in case of liver involvement

- PT-INR/PTT ≤ 1.5 x ULN

- Serum creatinine ≤ 2 times ULN

- Calculated creatinine clearance (CLcr) ≥ 40 ml/min (Cockcroft-Gault formula)

- Written informed consent

- Negative serum pregnancy test within 3 days prior to start of dosing premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥ 1 year.

Fertile men and women must have an effective method of contraception during treatment and for at least 3 months after completion of treatment as directed by their physician. Effective methods of contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence where lifestyle of the patient ensures compliance (Periodic abstinence and withdrawal are not acceptable methods of contraception).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 carcinomatous meningitis or leptomeningeal disease


- Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)


- Any person being in an institution on assignment of the respective authority against
his/her own will


- Any medical, mental or psychological condition which in the opinion of the
investigator would not permit the patient to complete the study or understand the
patient information


- Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of
any grade or QTcF interval > 470ms


- Patients with known interstitial fibrosis or interstitial lung disease


- Any of the following within 3 months prior to first crizotinib administration:


Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack

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Lung Cancer, Adenocarcinoma, NSCLCEUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer
NCT02183870
  1. Heidelberg, Baden-Würtemberg
  2. Frankfurt a.M., Hessen
  3. Großhansdorf, Schleswig-Holstein
  4. Berlin,
  5. Cologne,
  6. Tübingen,
  7. A Coruna,
  8. Alicante,
  9. Barcelona,
  10. Barcelona,
  11. Las Palmas de Gran Canaria,
  12. Madrid,
  13. Majadahonda,
  14. Malaga,
  15. Palma de Mallorca,
  16. Sevilla,
  17. Valencia,
  18. Basel,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer
Official Title  ICMJE EUCROSS: A Phase II Trial to Evaluate Efficacy and Safety of Crizotinib Treatment in Advanced Adenocarcinoma of the Lung Harbouring ROS1 Translocations
Brief Summary EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with 250mg crizotinib bid until progression or intolerable toxicity.
Detailed Description EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. In individual treatment attempts and an ongoing phase I trial crizotinib has shown remarkable effects on this selected subgroup of lung cancer patients. Crizotinib is a tyrosine kinase inhibitor, blocking the catalytic activity of rearranged ALK and ROS1 as well as MET. The patients eligible for the trial will be treated with 250mg crizotinib twice-daily. Tumor response to treatment will be assessed every 6 weeks by CT or MRI scans. In case of progression treatment beyond may be conducted if clinically indicated. To identify mechanisms of resistance to crizotinib treatment, an optional re-biopsy may be performed in these cases and fresh frozen tumor material will analyzed at the University of Cologne.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Adenocarcinoma
  • NSCLC
Intervention  ICMJE Drug: Crizotinib
250mg crizotinib bid until end of treatment
Other Name: Xalkori
Study Arms  ICMJE Experimental: Crizotinib
Patients are treated in this single-arm trial with oral crizotinib 250 mg b.i.d.. Treatment dose will be adjusted according to the protocol if indicated. Treatment will be conducted until disease progression or beyond disease progression according to the protocol if clinically indicated.
Intervention: Drug: Crizotinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 for ROS1 translocation by central FISH-testing
  • 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
  • Absolute neutrophil count (ANC) ? 1,000 /mm3
  • Platelet count ? 50 000/µL
  • Total bilirubin ? 2 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) ? 2,5 x ULN or ? 5 x ULN in case of liver involvement
  • PT-INR/PTT ? 1.5 x ULN
  • Serum creatinine ? 2 times ULN
  • Calculated creatinine clearance (CLcr) ? 40 ml/min (Cockcroft-Gault formula)
  • Written informed consent
  • Negative serum pregnancy test within 3 days prior to start of dosing premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ? 1 year.

Fertile men and women must have an effective method of contraception during treatment and for at least 3 months after completion of treatment as directed by their physician. Effective methods of contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence where lifestyle of the patient ensures compliance (Periodic abstinence and withdrawal are not acceptable methods of contraception).

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 carcinomatous meningitis or leptomeningeal disease
  • Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)
  • Any person being in an institution on assignment of the respective authority against his/her own will
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  • Ongoing cardiac dysrhythmias of CTCAE grade ?2, uncontrolled atrial fibrillation of any grade or QTcF interval > 470ms
  • Patients with known interstitial fibrosis or interstitial lung disease
  • Any of the following within 3 months prior to first crizotinib administration:

Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183870
Other Study ID Numbers  ICMJE EUCROSS
2013-002737-38 ( EudraCT Number )
DRKS00005409 ( Other Identifier: DRKS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Juergen Wolf, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE
  • Spanish Lung Cancer Group
  • Pfizer
Investigators  ICMJE
Principal Investigator:Juergen Wolf, Prof. Dr. med.Uniklinik Köln, Department I for Internal Medicine, LCGC
PRS Account University of Cologne
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP