AzTrials
AzTrials

Carcinoma, Non-Small Cell-LungPhase 1/2NCT01039948

A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer

A Phase 1/2 study testing AV-299 + gefitinib and Gefitinib in people with Carcinoma, Non-Small Cell-Lung and Lung Neoplasms, run by AVEO Pharmaceuticals, Inc. at 26 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AV-299 + gefitinib and Gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
26 sitesin 7 countries
Study dates
Dec 2009to Aug 2013
Phase
Phase 1/2
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

  • Asian ethnicity.
  • ECOG performance status of 0-2.
  • Phase 1b (only): Diagnosis of one of the following unresectable NSCLC with or without prior therapy advanced solid tumor that progressed after standard therapy
  • Phase 2 only: Histologic or cytologic confirmation of unresectable locally advanced or metastatic stage IIIB/IV lung adenocarcinoma with at least one measurable lesion, per Response Evaluation Criteria in Solid Tumors (RECIST-Version 1.1).
  • Phase 2 only: Never smoker or light ex-smoker.
  • Available tumor tissue for determination of EGFR mutational status and immunohistochemistry analysis
Show all 11Show fewer
  • Adequate hematologic, hepatic, renal and coagulation function
  • No active central nervous system metastases
  • Prior radiotherapy is allowed if 14 days from first dose of study drug and toxicity is resolved; additionally in Phase 2 only, ≥1 target lesion not irradiated or with definitive progression after prior radiation therapy.
  • Agreement to use effective contraception.
  • Phase 2 only: Subjects on Gefitinib monotherapy arm must have documented CR, PR, or SD for ≥12 weeks prior to disease progression in order to cross over to combination therapy arm.

Who cannot join

  • Phase 2 only: Prior chemotherapy or prior treatment with epidermal growth factor receptor (EGFR) inhibitor, including both tyrosine kinase inhibitors and monoclonal antibodies. There is no limit to the number of therapies for subject being considered for Phase 1b.
  • History of neoplasm other than the entry diagnosis.
  • Pregnancy or lactation.
  • Myocardial infarction within 6 months prior to initiation of study treatment.
  • A serious active infection.
  • Known human immunodeficiency virus infection.
Show all 15Show fewer
  • A serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
  • A major surgical procedure, open biopsy, or significant traumatic injury.
  • Thrombotic or embolic events.
  • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
  • Any condition that impairs absorption of oral agents or the subject's ability to swallow whole pills.
  • Diarrhea ≥ Grade 2 or active Inflammatory Bowel Disease.
  • Severe acute or chronic medical, psychiatric, or behavioral condition or laboratory abnormality.
  • Diagnosis of interstitial lung disease.
  • Any medications or treatments prohibited by the protocol.

Trial locations and contacts

26 sites in 7 countries.

26 sites in 7 countries

South Korea7 sites

  • Investigational Site 2

    Chungcheongbuk-do

  • Investigational Site 3

    Gyeonggi-do

  • Investigational Site 4

    Jeollanam-do

  • Investigational Site 5

    Seoul

  • Investigational Site 6

    Seoul

  • Investigational Site 7

    Seoul

  • Investigational Site 8

    Seoul

Other trials in South Korea

Taiwan7 sites

  • Investigational Site 16

    Changhua

  • Investigational Site 17

    Chiayi City

  • Investigational Site 18

    Taichung

  • Investigational Site 19

    Tainan

  • Investigational Site 20

    Taipei

  • Investigational Site 21

    Taipei

  • Investigational Site 22

    Taoyuan

Other trials in Taiwan

Thailand4 sites

  • Investigational Site 23

    Bangkok

  • Investigational Site 24

    Chiang Mai

  • Investigational Site 25

    KhonKaen

  • Investigational Site 26

    Songkhla

Other trials in Thailand

Malaysia3 sites

  • Investigational Site 10

    Kuala Lumpur

  • Investigational Site 9

    Kuala Lumpur

  • Investigational Site 11

    Kuala Pahang

Other trials in Malaysia

Philippines3 sites

  • Investigational Site 12

    Manila

  • Investigational Site 13

    Pasig

  • Investigational Site 14

    Quezon City

Other trials in Philippines

Hong Kong1 site

  • Investigational Site 1

    Shatin N.T.

Other trials in Hong Kong

Singapore1 site

  • Investigational Site 15

    Singapore

Other trials in Singapore

About this study

Official title: A Phase 1b/2 Study of AV-299 (Formerly SCH 900105) in Combination With Gefitinib in Asian Subjects With Non-Small Cell Lung Cancer (P06162)

During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumor. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion.

The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of AV-299 (formerly SCH900105) and gefitinib versus gefitinib alone in clinically selected Asian subjects with previously untreated lung adenocarcinoma who have a high likelihood of harboring activating EGFR mutations. Subjects who progress after initial disease control in the gefitinib alone arm may crossover to the combination arm.

Being tested
AV-299 + gefitinib, Gefitinib
Keywords
Neoplasms, Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histological Type, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases, Respiratory Tract Diseases, Gefitinib, Antineoplastic Agents, Therapeutic Uses, Pharmacologic Actions, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AV-299 + gefitinibBiological

    Also called Other name: ficlatuzumab, Formerly SCH 900105

    AV-299 is a humanized anti-HGF IgG1 monoclonal antibody directed against free HGF, ligand for c-Met tyrosine kinase receptor.

  • GefitinibDrug

    Also called Iressa®

    Gefitinib is a small molecule (drug) which selectively inhibits epidermal growth factor receptor's (EGFR) tyrosine kinase domain.

Study groups in NCT01039948
Study groupRoleWhat they receive
Phase 2: AV-299 + gefitinibExperimentalPhase 2: AV-299 (formerly SCH 900105) administered IV at RP2D (as determined by Phase 1b portion) in combination with gefitinib 250 mg/day orally.
Receives: Biological: AV-299 + gefitinib
Phase 2: GefitinibActive comparatorPhase 2: Gefitinib 250 mg/day, orally.
Receives: Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Dose Limiting Toxicity and Recommended Phase II Dose

    Measured: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereaftert

  2. Phase 2: Objective Response Rate

    Measured: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter

Secondary outcomes (2)

  1. Phase 1b: Cmax, Tmax, AUC, t1/2, clearance, and Vd

    Measured: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter

  2. Phase 2: Progression Free Survival, Overall Survival, Safety

    Measured: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01039948
Sponsor's protocol ID
P06162
Status last verified
Apr 2015
First submitted
23 Dec 2009
Last updated
8 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Tan EH, Lim WT, Ahn MJ, Ng QS, Ahn JS, Shao-Weng Tan D, Sun JM, Han M, Payumo FC, McKee K, Yin W, Credi M, Agarwal S, Jac J, Park K. Phase 1b Trial of Ficlatuzumab, a Humanized Hepatocyte Growth Factor Inhibitory Monoclonal Antibody, in Combination With Gefitinib in Asian Patients With NSCLC. Clin Pharmacol Drug Dev. 2018 Jun;7(5):532-542. doi: 10.1002/cpdd.427. Epub 2018 Jan 18.

    PubMed 29346833

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AV-299 + gefitinib and Gefitinib in people with Carcinoma, Non-Small Cell-Lung and Lung Neoplasms, run by AVEO Pharmaceuticals, Inc. at 26 sites in 7 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 11 inclusion and 15 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea, Taiwan, Thailand, Malaysia, Philippines and 2 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase Ib: Dose Limiting Toxicity and Recommended Phase II Dose (time frame: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereaftert). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01039948, which also lists 1 linked publication.

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 8 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in