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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00949624




Registration number
NCT00949624
Ethics application status
Date submitted
24/07/2009
Date registered
30/07/2009
Date last updated
19/01/2012

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
Sex
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
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
50
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00949624