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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00949624




Registration number
NCT00949624
Ethics application status
Date submitted
24/07/2009
Date registered
28/07/2009
Date last updated
18/01/2012

Titles & IDs
Public title
CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
A5301005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - AG-013736
Treatment: Drugs - Docetaxel

Experimental: Cohort 1 - 60 mg BID/ 75 mg/m2

Experimental: Cohort 2 - 100 mg BID/75 mg/m2

Experimental: Cohort 3 - 100 mg BID/100 mg/m2

Experimental: Cohort 4b - CP-868,596 + AG-013736 + TXT 75


Treatment: Drugs: CP-868,596
Oral tablet 60 mg BID continuous

Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks

Treatment: Drugs: CP-868,596
Oral tablet 100 mg BID continuous

Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks

Treatment: Drugs: CP-868,596
Oral tablet 100 mg BID continuous

Treatment: Drugs: Docetaxel
Intravenous 100 mg/m2 every three weeks

Treatment: Drugs: CP-868,596
Oral tablet 60 mg BID continuous

Treatment: Drugs: AG-013736
Oral tablet 5 mg BID continuous

Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First-cycle Dose Limiting Toxicities
Timepoint [1] 0 0
2.5 years
Secondary outcome [1] 0 0
Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule
Timepoint [1] 0 0
2.5 years
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
2.5 years
Secondary outcome [3] 0 0
To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination
Timepoint [3] 0 0
2.5 years
Secondary outcome [4] 0 0
To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)
Timepoint [5] 0 0
2.5 years
Secondary outcome [6] 0 0
To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters
Timepoint [6] 0 0
2.5 years
Secondary outcome [7] 0 0
To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI
Timepoint [7] 0 0
2.5 years
Secondary outcome [8] 0 0
To assess any preliminary clinical evidence of anti-tumor activity using RECIST
Timepoint [8] 0 0
2.5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arog Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00949624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications