NCT00949624

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

January 19, 2012

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

July 24, 2009

Last Update Submit

January 18, 2012

Conditions

Advanced Solid Tumors

Keywords

PDGFr Inhibition;VEGFr inhibition;targeted therapy

Outcome Measures

Primary Outcomes (1)

  • First-cycle Dose Limiting Toxicities

    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

    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

    2.5 years

  • To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination

    2.5 years

  • To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination

    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.)

    2.5 years

  • +3 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

60 mg BID/ 75 mg/m2

Drug: CP-868,596Drug: Docetaxel

Cohort 2

EXPERIMENTAL

100 mg BID/75 mg/m2

Drug: CP-868,596Drug: Docetaxel

Cohort 3

EXPERIMENTAL

100 mg BID/100 mg/m2

Drug: CP-868,596Drug: Docetaxel

Cohort 4b

EXPERIMENTAL

CP-868,596 + AG-013736 + TXT 75

Drug: CP-868,596Drug: AG-013736Drug: Docetaxel

Interventions

CP-868,596DRUG

Oral tablet 60 mg BID continuous

Cohort 1
DocetaxelDRUG

Intravenous 75 mg/m2 every three weeks

Cohort 1
AG-013736DRUG

Oral tablet 5 mg BID continuous

Cohort 4b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Related Links

MeSH Terms

Interventions

crenolanibDocetaxelAxitinib

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 30, 2009

Study Start

December 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 19, 2012

Record last verified: 2011-08

Locations

US(1)AU(1)