NCT00735904

Brief Summary

This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer

Trial Health

90
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Typical duration for phase_2

Geographic Reach
4 countries

10 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

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

August 13, 2008

Results QC Date

November 30, 2012

Last Update Submit

November 30, 2012

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Keywords

AG-013736axitinibcisplatingemcitabineNSCLCsquamous celllung cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Objective Response (OR)

    Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.

    Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)

Secondary Outcomes (3)

  • Overall Survival (OS)

    Baseline until death or assessed every 2 months (up to 28 days after the last dose)

  • Progression Free Survival (PFS)

    Baseline, assessed every 2 months (up to 28 days after the last dose)

  • Duration of Response (DR)

    Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)

Study Arms (1)

AG-013736/Cisplatin/Gemcitabine

EXPERIMENTAL
Drug: AG-013736Drug: gemcitabineDrug: cisplatin

Interventions

AG-013736DRUG

AG-013736 5 mg tablets orally, twice daily, until disease progression

Also known as: axitinib
AG-013736/Cisplatin/Gemcitabine
gemcitabineDRUG

200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m\^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles

AG-013736/Cisplatin/Gemcitabine
cisplatinDRUG

1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m\^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles

AG-013736/Cisplatin/Gemcitabine

Eligibility Criteria

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

You may qualify if:

  • Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
  • Candidate for primary treatment with cisplatin and gemcitabine
  • Presence of measurable disease by RECIST
  • Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

You may not qualify if:

  • Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
  • One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
  • History of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
  • NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
  • Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
  • Untreated brain metastases.
  • Need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), NSAID or other medications known to inhibit platelet function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Torun, 87-100, Poland

Location

Pfizer Investigational Site

Wodzislaw Sl., 44-300, Poland

Location

Pfizer Investigational Site

Cluj-Napoca, Cluj, 400015, Romania

Location

Pfizer Investigational Site

Bucharest, 022328, Romania

Location

Pfizer Investigational Site

Oradea, 410032, Romania

Location

Pfizer Investigational Site

Parktown, 2193, South Africa

Location

Pfizer Investigational Site

Dnipropetrovsk, 49102, Ukraine

Location

Pfizer Investigational Site

Donetsk, 83092, Ukraine

Location

Pfizer Investigational Site

Kyiv, 04107, Ukraine

Location

Pfizer Investigational Site

Lviv, 79031, Ukraine

Location

Related Publications (1)

  • Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6.

    PMID: 25929582DERIVED

Related Links

MeSH Terms

Conditions

CarcinomaCarcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

AxitinibGemcitabineCisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

December 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 3, 2013

Results First Posted

January 3, 2013

Record last verified: 2012-11

Locations

RO(3)ZA(1)PL(2)UA(4)