CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

Phase I Study To Determine The Maximally Tolerated Dose Of Oral, Daily CP-868,596 And CP-868,596 Plus AG-013736 When Given In Combination With Docetaxel Administered Every 3 Weeks To Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949624
• Other study ID #: A5301005
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2009
• Last updated: January 18, 2012
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: August 2011
• Source: Arog Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be =18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy.

• Patients with primary brain tumors are not eligible.

• Have at least one site of measurable disease.

Exclusion Criteria:

• Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C).

• Received tamoxifen within 4 weeks prior to study entry.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• CP-868,596
Oral tablet 60 mg BID continuous
• Docetaxel
Intravenous 75 mg/m2 every three weeks
• CP-868,596
Oral tablet 100 mg BID continuous
• Docetaxel
Intravenous 75 mg/m2 every three weeks
• CP-868,596
Oral tablet 100 mg BID continuous
• Docetaxel
Intravenous 100 mg/m2 every three weeks
• CP-868,596
Oral tablet 60 mg BID continuous
• AG-013736
Oral tablet 5 mg BID continuous
• Docetaxel
Intravenous 75 mg/m2 every three weeks

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	East Melbourne	Victoria
United States	Pfizer Investigational Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arog Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-cycle Dose Limiting Toxicities		2.5 years	Yes
Secondary	Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule		2.5 years	Yes
Secondary	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		2.5 years	Yes
Secondary	To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination		2.5 years	Yes
Secondary	To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination		2.5 years	Yes
Secondary	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	No
Secondary	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	No
Secondary	To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI		2.5 years	No
Secondary	To assess any preliminary clinical evidence of anti-tumor activity using RECIST		2.5 years	No

External Links

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