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Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma, Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor, Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1, Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma, Locally Advanced and/or Metastatic Clear Cell Sarcoma, Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma

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Trial Information

Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")

Inclusion Criteria


General inclusion criteria:

- Locally advanced and/or metastatic anaplastic large cell lymphoma

- Locally advanced and/or metastatic inflammatory myofibroblastic tumor

- Locally advanced and/or metastatic papillary renal cell carcinoma type 1

- Locally advanced and/or metastatic alveolar soft part sarcoma

- Locally advanced and/or metastatic clear cell sarcoma

- Locally advanced and/or metastatic alveolar rhabdomyosarcoma.

- The above malignancies must be incurable by conventional surgery, radiotherapy,
systemic therapy or any other means.

- Proven presence of specific ALK and/or MET pathway alteration in tumor tissue is not
mandatory for patient registration.

- Availability of tumor material for central pathology review

- Written informed consent

- Measurable disease according to RECIST 1.1

- Patients with brain metastases are eligible if treated and/or neurologically stable
with no ongoing requirement for corticosteroids (off steroids for at least 2 weeks)
and not taking contraindicated medications. Absence of spinal cord compression unless
treated with the patient attaining good pain control and stable or recovered
neurologic function.

- No carcinomatous meningitis or leptomeningeal disease.

- Any previous systemic anticancer therapy must have been completed at least 4 weeks
prior to initiation of study medication.

- No treatment with any other investigational drug within the past 4 weeks or within
less than 4 half-life times of the investigational drug before treatment with
crizotinib (whatever is the longest period).

- No prior therapy directly targeting ALK and/or MET, no previous treatment with
crizotinib.

- Major surgery must have been completed at least 4 weeks prior to initiation of study
medication.

- Prior palliative radiotherapy must have been completed at least 24 hrs prior to
initiation of study medication, and minor surgical procedures must have been
completed at least two weeks prior to the initiation of study medication.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Adequate hematological function: ANC ≥ 1 x 109/L, platelets ≥ 30 x 109/L and
hemoglobin ≥ 8 g/dL.

- Adequate bone marrow, renal and hepatic functions

- All related adverse events from previous therapies must have recovered to ≤ Grade 1
(except alopecia). No persistence of adverse events from prior anti-cancer therapy
deemed clinically relevant.

- No acute or chronic severe gastrointestinal conditions such as diarrhea or
ulcerations.

- Normal cardiac function and no cerebrovascular accident including transient ischemic
attack.

- No current congestive heart failure.

- No ongoing cardiac dysrhythmias of NCI CTCAE Grade >2.

- No uncontrolled atrial fibrillation of any grade.

- QTc interval <470 msec.

- Absence of interstitial lung disease.

- No concurrent use of drugs or foods that are known potent CYP3A4 inhibitors

- No concurrent use of drugs that are known potent CYP3A4 inducers

- No concomitant intercurrent illnesses

- Effective contraception method (if applicable)

Disease-specific inclusion criteria for patients with anaplastic large cell lymphoma

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or advanced disease.

- Patient must have received previous systemic chemotherapy (usually a CHOP-like
multidrug combination, if not medically contraindicated, with or without monoclonal
antibodies), and may not qualify for further conventional therapy with curative
intent.

- No pretreatment limitations (including autologous or allogeneic stem cell- or bone
marrow transplantation), provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with inflammatory myofibroblastic tumor

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or metastatic disease.

- No mandatory pretreatment.

- No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with papillary renal cell carcinoma type
1

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or metastatic disease.

- No mandatory pretreatment.

- No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with clear cell sarcoma

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or metastatic disease.

- No mandatory pretreatment.

- No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with alveolar soft part sarcoma

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or metastatic disease.

- No mandatory pretreatment.

- No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with alveolar rhabdomyosarcoma

- Patient may have received previous systemic treatment, surgery and/or radiotherapy
for localized, locally advanced or metastatic disease.

- Patient must have received previous systemic chemotherapy (usually
anthracycline-based, if not medically contraindicated), and may not qualify for
further conventional therapy with curative intent.

- No pretreatment limitations, provided all other patient selection criteria are met.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity of crizotinib

Outcome Description:

To study the antitumor activity of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or MET

Safety Issue:

No

Principal Investigator

Patrick Schöffski, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven

Authority:

Austria: Agency for Health and Food Safety

Study ID:

EORTC-90101

NCT ID:

NCT01524926

Start Date:

September 2012

Completion Date:

December 2017

Related Keywords:

  • Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma
  • Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor
  • Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1
  • Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma
  • Locally Advanced and/or Metastatic Clear Cell Sarcoma
  • Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma
  • Phase 2
  • Crizotinib
  • Anaplastic large cell lymphoma
  • Inflammatory myofibroblastic tumor
  • Papillary renal cell carcinoma type 1
  • Alveolar soft part sarcoma
  • Clear cell sarcoma
  • Alveolar rhabdomyosarcoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Rhabdomyosarcoma
  • Lymphoma, Large-Cell, Anaplastic
  • Sarcoma, Clear Cell
  • Rhabdomyosarcoma, Alveolar
  • Sarcoma, Alveolar Soft Part
  • Granuloma, Plasma Cell
  • Sarcoma

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