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

April 6, 2015 updated by: AVEO Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin N.T., Hong Kong
        • Investigational Site 1
  • Korea, Republic of
      • Chungcheongbuk-do, Korea, Republic of
        • Investigational Site 2
      • Gyeonggi-do, Korea, Republic of
        • Investigational Site 3
      • Jeollanam-do, Korea, Republic of
        • Investigational Site 4
      • Seoul, Korea, Republic of
        • Investigational Site 5
      • Seoul, Korea, Republic of
        • Investigational Site 6
      • Seoul, Korea, Republic of
        • Investigational Site 7
      • Seoul, Korea, Republic of
        • Investigational Site 8
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Investigational site 10
      • Kuala Lumpur, Malaysia
        • Investigational Site 9
      • Pahang, Malaysia
        • Investigational site 11
  • Philippines
      • Manila, Philippines
        • Investigational site 12
      • Pasig City, Philippines
        • Investigational site 13
      • Quezon City, Philippines
        • Investigational site 14
  • Singapore
      • Singapore, Singapore
        • Investigational site 15
  • Taiwan
      • Changhua, Taiwan
        • Investigational site 16
      • Chiayi, Taiwan
        • Investigational site 17
      • Taichung, Taiwan
        • Investigational site 18
      • Tainan, Taiwan
        • Investigational site 19
      • Taipei, Taiwan
        • Investigational site 20
      • Taipei, Taiwan
        • Investigational site 21
      • Taoyuan, Taiwan
        • Investigational site 22
  • Thailand
      • Bangkok, Thailand
        • Investigational site 23
      • Chiang Mai, Thailand
        • Investigational site 24
      • KhonKaen, Thailand
        • Investigational site 25
      • Songkla, Thailand
        • Investigational site 26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2: AV-299 + gefitinib
Phase 2: AV-299 (formerly SCH 900105) administered IV at RP2D (as determined by Phase 1b portion) in combination with gefitinib 250 mg/day orally.
Biological: AV-299 + gefitinib
AV-299 is a humanized anti-HGF IgG1 monoclonal antibody directed against free HGF, ligand for c-Met tyrosine kinase receptor.
Other Names:
  • Other name: ficlatuzumab, Formerly SCH 900105
Active Comparator: Phase 2: Gefitinib
Phase 2: Gefitinib 250 mg/day, orally.
Drug: Gefitinib
Gefitinib is a small molecule (drug) which selectively inhibits epidermal growth factor receptor's (EGFR) tyrosine kinase domain.
Other Names:
  • Iressa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereaftert
Phase 2: Objective Response Rate
Time Frame: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter
Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 1b: Cmax, Tmax, AUC, t1/2, clearance, and Vd
Time Frame: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter
Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter
Phase 2: Progression Free Survival, Overall Survival, Safety
Time Frame: Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter
Every 4 weeks for the first 4 months of treatment period, every 8 weeks thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVEO Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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