NCT00528619

Brief Summary

This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Geographic Reach
2 countries

3 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

November 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

3.4 years

First QC Date

September 10, 2007

Last Update Submit

April 7, 2011

Conditions

Neoplasms

Keywords

Solid tumor malignancynon-small cell lung cancersunitinibpemetrexedPhase 1Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.

    From screening until at least 28 days beyond discontinuation of study treatment

Secondary Outcomes (2)

  • To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered.

    From screening until disease progression or discontinuation of the study

  • To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma.

    From screening until disease progression or discontinuation of the study

Study Arms (1)

A

EXPERIMENTAL
Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin

Interventions

Sunitinib, Pemetrexed, Cisplatin, CarboplatinDRUG

Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg\*min/mL until progression or unacceptable toxicity.

Also known as: Sutent, SU011248, Alimta, Platinol, Paraplatin
A

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
  • Patient has a good performance status (ECOG 0 or 1).

You may not qualify if:

  • Prior treatment with either pemetrexed or SU011248.
  • Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
  • Hypertension that cannot be controlled by medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungMesothelioma

Interventions

SunitinibPemetrexedCisplatinCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic Chemicals

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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

CA(2)US(1)