A Phase 1 interventional study of Crizotinib plus VEGF inhibitor combinations and Crizotinib plus axitinib in Carcinoma, Renal Cell, Glioblastoma and Carcinoma, Hepatocellular, sponsored by Pfizer. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-20.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment while the majority of patients will eventually develop evasive resistance and exhibit disease progression while on therapy. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute significantly to VEGF inhibitor resistance such that combining a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with individual VEGF inhibitors. Three combinations will be prioritized, namely crizotinib plus axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with either axitinib and/or sunitinib.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
Browse Carcinoma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
Drug: Crizotinib plus VEGF inhibitor combinations
Patients with histologically confirmed metastatic renal cell cancer with no prior systemic therapy directed at the malignant tumor.
Drug: Crizotinib plus axitinib · Drug: Crizotinib plus sunitinib
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.
Drug: Crizotinib plus axitinib · Drug: Crizotinib plus sunitinib
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.
Drug: Crizotinib plus bevacizumab
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.
Drug: Crizotinib plus sorafenib
Three combinations will be prioritized, namely crizotinib plus axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with either axitinib and/or sunitinib. All study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
Study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
Dose Limiting Toxicities (DLTs).
Time frame: 12 months
Duration of Response (DR)
Time frame: 24 months
Progression free survival (PFS)
Time frame: 24 months
Area under the plasma concentration versus time curve (AUC) of crizotinib and each VEGF inhibitor
Time frame: 24 months
Best overall response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 or , in the case of GBM (glioblastoma multiforme , RANO (Response Assessment in Neuro-Oncology) criteria.
Time frame: 24 months
Overall survival (OS) up to 12 months
Time frame: 24 months
Pre- and post-dose levels of soluble peripheral blood biomarkers.
Time frame: 24 months
Tumor tissue biomarkers.
Time frame: 18 months
6-month progression free survival proportion (PFS6) for glioblastoma patients
Time frame: 24 months
Peak plasma concentration (Cmax) of crizotinib and each VEGF inhibitor
Time frame: 24 months
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.