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A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 60 mg BID/ 75 mg/m2 |
|
| Cohort 2 | Experimental | 100 mg BID/75 mg/m2 |
|
| Cohort 3 | Experimental | 100 mg BID/100 mg/m2 |
|
| Cohort 4b | Experimental | CP-868,596 + AG-013736 + TXT 75 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-868,596 | Drug | Oral tablet 60 mg BID continuous |
| |
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| First-cycle Dose Limiting Toxicities | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule | 2.5 years | |
| Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C577197 | crenolanib |
| D000077143 | Docetaxel |
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
Intravenous 75 mg/m2 every three weeks |
|
| CP-868,596 | Drug | Oral tablet 100 mg BID continuous |
|
| Docetaxel | Drug | Intravenous 75 mg/m2 every three weeks |
|
| CP-868,596 | Drug | Oral tablet 100 mg BID continuous |
|
| Docetaxel | Drug | Intravenous 100 mg/m2 every three weeks |
|
| CP-868,596 | Drug | Oral tablet 60 mg BID continuous |
|
| AG-013736 | Drug | Oral tablet 5 mg BID continuous |
|
| Docetaxel | Drug | Intravenous 75 mg/m2 every three weeks |
|
| 2.5 years |
| To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination | 2.5 years |
| To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination | 2.5 years |
| Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.) | 2.5 years |
| To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters | 2.5 years |
| To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI | 2.5 years |
| To assess any preliminary clinical evidence of anti-tumor activity using RECIST | 2.5 years |
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |