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A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.

Last updated on February 20, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma, Glioblastoma, Hepatocellular Carcinoma
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.
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- Dose Escalation Population: Histological or cytological diagnosis of
advanced/metastatic solid tumor that is resistant to standard therapy or for which no
standard therapy is available. Lesions may be measurable or non measurable.

- Expansion Population 1: Patients with histologically confirmed metastatic renal cell
cancer with no prior systemic therapy directed at the malignant tumor.

- Expansion Population 2: Patients with histologically confirmed metastatic renal cell
cancer whose prior systemic therapy directed at the malignant tumor was single agent
VEGF inhibitor and who now have acquired resistance to this treatment. Resistance is
defined as progression following an initial response (complete or partial), or stable
disease for at least 6 months on single agent VEGF inhibitor.

- Expansion Population 3: Patients with histologically confirmed glioblastoma whose
disease has failed on previous therapy, and which must have included treatment with
external beam radiation and temozolomide chemotherapy, and who now have
radiographically recurrent or progressive disease.

- Expansion Population 4: Patients with histologically confirmed advanced-stage
(unresectable or metastatic) hepatocellular carcinoma who have not received previous
systemic therapy directed at the malignant tumor will be eligible to receive
crizotinib plus sorafenib, should this combination be tested. Eligibility criteria
also include normal hepatic function or Child-Pugh hepatic function class A.

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

- Patients with hemorrhagic brain metastases or with known symptomatic brain metastases
requiring steroids.

- Major surgery within 4 weeks of starting study treatment.

- Radiation therapy within 2 weeks of starting study treatment.

- Hypertension that cannot be controlled with medications (>150/90 mmHg despite optimal
medical therapy).

- For glioblastoma patients: Prior treatment of glioblastoma with Gliadel wafers,
stereotactic radiation, or brachytherapy unless there is pathological or definitive
radiological evidence (PET scan or perfusion MRI) of recurrent tumor or unless there
is new enhancement outside of the radiation field. History of Grade 2 or greater acute
intracranial hemorrhage. Radiation therapy (RT) for glioblastoma within 3 months
unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new
enhancement on MRI outside of the RT treatment field.Concomitant treatment with
therapeutic doses of anticoagulants (low dose warfarin (Coumadin) up to 2 mg PO daily
for deep vein thrombosis prophylaxis is allowed).

NCT01441388
Pfizer
Withdrawn
A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now