Clinical trial NCT00949624: CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: PDGFr Inhibition;
VEGFr inhibition;
targeted therapy
Lead sponsor: Arog Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: First-cycle Dose Limiting Toxicities
timeFrame: 2.5 years
Secondary outcomes:
measure: Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule
timeFrame: 2.5 years
measure: 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
timeFrame: 2.5 years
measure: To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination
timeFrame: 2.5 years
measure: To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination
timeFrame: 2.5 years
measure: Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)
timeFrame: 2.5 years
measure: To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters
timeFrame: 2.5 years
measure: To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI
timeFrame: 2.5 years
measure: To assess any preliminary clinical evidence of anti-tumor activity using RECIST
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: