Advanced Solid TumorsPhase 1NCT00949624
CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors
A Phase 1 study testing CP-868,596, Docetaxel and AG-013736 in people with Advanced Solid Tumors, run by Arog Pharmaceuticals, Inc. at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CP-868,596, Docetaxel and AG-013736
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2005to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pfizer Investigational Site
Durham, North Carolina, 27710
About this study
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
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- CP-868,596, Docetaxel, AG-013736
- Keywords
- PDGFr Inhibition;, VEGFr inhibition;, targeted therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-868,596Drug
Oral tablet 60 mg BID continuous
DocetaxelDrug
Intravenous 75 mg/m2 every three weeks
CP-868,596Drug
Oral tablet 100 mg BID continuous
DocetaxelDrug
Intravenous 75 mg/m2 every three weeks
CP-868,596Drug
Oral tablet 100 mg BID continuous
DocetaxelDrug
Intravenous 100 mg/m2 every three weeks
CP-868,596Drug
Oral tablet 60 mg BID continuous
AG-013736Drug
Oral tablet 5 mg BID continuous
DocetaxelDrug
Intravenous 75 mg/m2 every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 60 mg BID/ 75 mg/m2 Receives: Drug: CP-868,596; Drug: Docetaxel |
| Cohort 2 | Experimental | 100 mg BID/75 mg/m2 Receives: Drug: CP-868,596; Drug: Docetaxel |
| Cohort 3 | Experimental | 100 mg BID/100 mg/m2 Receives: Drug: CP-868,596; Drug: Docetaxel |
| Cohort 4b | Experimental | CP-868,596 + AG-013736 + TXT 75 Receives: Drug: CP-868,596; Drug: AG-013736; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-cycle Dose Limiting Toxicities
Measured: 2.5 years
Secondary outcomes (8)
Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule
Measured: 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
Measured: 2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination
Measured: 2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination
Measured: 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.)
Measured: 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
Measured: 2.5 years
To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI
Measured: 2.5 years
To assess any preliminary clinical evidence of anti-tumor activity using RECIST
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startDec 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arog Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949624
- Sponsor's protocol ID
- A5301005
- Status last verified
- Aug 2011
- First submitted
- 24 Jul 2009
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00949624
- Acronym / sponsor ID
- A5301005
- Conditions
- Advanced Solid Tumors
- Keywords
- PDGFr Inhibition;, VEGFr inhibition;, targeted therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Arog Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CP-868,596, Drug: Docetaxel60 mg BID/ 75 mg/m2 |
| Cohort 2 | Experimental | Drug: CP-868,596, Drug: Docetaxel100 mg BID/75 mg/m2 |
| Cohort 3 | Experimental | Drug: CP-868,596, Drug: Docetaxel100 mg BID/100 mg/m2 |
| Cohort 4b | Experimental | Drug: CP-868,596, Drug: AG-013736, Drug: DocetaxelCP-868,596 + AG-013736 + TXT 75 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-868,596Oral tablet 60 mg BID continuous | Drug | Cohort 1 |
| DocetaxelIntravenous 75 mg/m2 every three weeks | Drug | Cohort 1 |
| CP-868,596Oral tablet 100 mg BID continuous | Drug | Cohort 2 |
| DocetaxelIntravenous 75 mg/m2 every three weeks | Drug | Cohort 2 |
| CP-868,596Oral tablet 100 mg BID continuous | Drug | Cohort 3 |
| DocetaxelIntravenous 100 mg/m2 every three weeks | Drug | Cohort 3 |
| CP-868,596Oral tablet 60 mg BID continuous | Drug | Cohort 4b |
| AG-013736Oral tablet 5 mg BID continuous | Drug | Cohort 4b |
| DocetaxelIntravenous 75 mg/m2 every three weeks | Drug | Cohort 4b |
Primary outcome
First-cycle Dose Limiting Toxicities
Time frame: 2.5 years
8 secondary outcomes
Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule
Time frame: 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
Time frame: 2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination
Time frame: 2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination
Time frame: 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.)
Time frame: 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
Time frame: 2.5 years
To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI
Time frame: 2.5 years
To assess any preliminary clinical evidence of anti-tumor activity using RECIST
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Advanced Solid Tumors
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-868,596, Docetaxel and AG-013736 in people with Advanced Solid Tumors, run by Arog Pharmaceuticals, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-cycle Dose Limiting Toxicities (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.