NCT00768755

Brief Summary

AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Trial Health

98
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
11 countries

52 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

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
29 days until next milestone

Results Posted

Study results publicly available

March 30, 2012

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

October 7, 2008

Results QC Date

March 1, 2012

Last Update Submit

October 6, 2015

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

non-squamous NSCLCaxitinibpemetrexed/cisplatin

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]); death was determined from AE data (where the outcome was "Death") or from the end of study data.

    Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks

Secondary Outcomes (5)

  • Overall Survival (OS)

    Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant

  • Percentage of Participants With Objective Response (OR)

    Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks

  • Duration of Response (DR)

    Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks

  • Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score

    Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)

  • Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score

    Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT

Study Arms (5)

I

EXPERIMENTAL

Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Drug: axitinib

II

EXPERIMENTAL

Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Drug: axitinib

III

ACTIVE COMPARATOR

pemetrexed and cisplatin

Drug: chemotherapy

IV

EXPERIMENTAL

Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Drug: axitinib

V

ACTIVE COMPARATOR

pemetrexed and cisplatin

Drug: chemotherapy

Interventions

axitinibDRUG

5mg BID po up to max 10mg BID po

Also known as: AG-013736
I
chemotherapyDRUG

Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles

Also known as: alimta
III

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
  • Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
  • Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
  • Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
  • Candidate for primary treatment with cisplatin and pemetrexed

You may not qualify if:

  • Any histological/cytological evidence of predominantly squamous NSCLC.
  • Small cell or carcinoid lung cancer patients are also ineligible.
  • NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
  • Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
  • Prior treatment with a VEGF or VEGFR inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Pfizer Investigational Site

Huntsville, Alabama, 35805, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30341, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

Macon, Georgia, 31217, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30060, United States

Location

Pfizer Investigational Site

Sandy Springs, Georgia, 30342, United States

Location

Pfizer Investigational Site

Bloomington, Illinois, 61701, United States

Location

Pfizer Investigational Site

Peoria, Illinois, 61615, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033-0850, United States

Location

Pfizer Investigational Site

West Reading, Pennsylvania, 19611, United States

Location

Pfizer Investigational Site

East Providence, Rhode Island, 02914, United States

Location

Pfizer Investigational Site

East Providence, Rhode Island, 02915, United States

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Lido Di Camaiore (LU), 55043, Italy

Location

Pfizer Investigational Site

Orbassano (TO), 10043, Italy

Location

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Location

Pfizer Investigational Site

Lubin, 59-300, Poland

Location

Pfizer Investigational Site

Otwock, 05-400, Poland

Location

Pfizer Investigational Site

Piła, 64-920, Poland

Location

Pfizer Investigational Site

Poznan, 60-569, Poland

Location

Pfizer Investigational Site

Poznan, 61-485, Poland

Location

Pfizer Investigational Site

Prabuty, 82-550, Poland

Location

Pfizer Investigational Site

Warsaw, 00-909, Poland

Location

Pfizer Investigational Site

Bacau, Bacău, 600114, Romania

Location

Pfizer Investigational Site

Iași, Iaşi, 700106, Romania

Location

Pfizer Investigational Site

Moscow, 115478, Russia

Location

Pfizer Investigational Site

Pyatigorsk, 357502, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194044, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 197089, Russia

Location

Pfizer Investigational Site

Terrassa, Barcelona, 08221, Spain

Location

Pfizer Investigational Site

Castellon, Castellon, 12002, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28007, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Palma de Mallorca, Palma de Mallorca, 07010, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41009, Spain

Location

Pfizer Investigational Site

Basel, CH-4016, Switzerland

Location

Pfizer Investigational Site

Basel, CH-4031, Switzerland

Location

Pfizer Investigational Site

Bruderholz, CH-4101, Switzerland

Location

Pfizer Investigational Site

Liestal, CH-4410, Switzerland

Location

Pfizer Investigational Site

Taichung, 402, Taiwan

Location

Pfizer Investigational Site

Taichung, 40705, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Taipei, 112, Taiwan

Location

Pfizer Investigational Site

Dnipropetrovsk, 49102, Ukraine

Location

Pfizer Investigational Site

Kyiv, 03115, Ukraine

Location

Pfizer Investigational Site

Romford, Essex, RM7 0AG, United Kingdom

Location

Pfizer Investigational Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Pfizer Investigational Site

Bournemouth, BH7 7DW, United Kingdom

Location

Pfizer Investigational Site

Brighton, BN2 5BE, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Middlesex, HA6 2RN, United Kingdom

Location

Pfizer Investigational Site

Poole, BH15 2JB, United Kingdom

Location

Related Publications (1)

  • Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.

    PMID: 24766732DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

AxitinibDrug TherapyPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTherapeuticsGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

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 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

January 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

October 28, 2015

Results First Posted

March 30, 2012

Record last verified: 2015-10

Locations

RO(2)JP(1)UA(2)PL(7)ES(6)TW(4)US(12)CH(4)IT(3)RU(4)GB(7)