Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung

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Brief Title

Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung

Official Title

Phase II, Randomized, Open-label Study of the IGF-1R Inhibitor AXL1717 Compared to Docetaxel in Patients With Previously Treated, Locally Advanced, or Metastatic Squamous Cell Carcinoma or Adenocarcinoma of the Lung

Brief Summary

      The purpose of this study is to compare effectiveness and safety of experimental anticancer
      medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma
      of the lung.
    

Detailed Description

      Non-Small-Cell lung Cancer (NSCLC) is the most common form of lung cancer, and treatment with
      cytotoxic chemotherapy only provides a 10% reduction in the risk of death in patients with
      advanced NSCLC. One-third of all non-resectable advanced NSCLC patients in second line do not
      receive chemotherapy treatment at all. In the absence of treatment the Progression-Free
      Survival (PFS) for NSCLC patients is dismal, in the range of 6-8 weeks, and treatment only
      modestly improves the median PFS to 10-11 weeks. Therefore, because of an overall poorer
      prognosis for patients with advanced NSCLC, development of new agents is urgently needed.

      AXL1717 is a small molecule experimental product developed by Axelar AB as anticancer agent
      for oral administration. AXL1717 inhibits the insulin-like growth factor 1 (IGF-1), which is
      often over expressed in lung tumors and can mediate the proliferation of lung cancer cells
      and resistance to therapy. Results of previous preclinical and clinical studies indicate that
      AXL1717 will be tolerable and effective in patients with previously-treated, advanced
      squamous cell carcinoma (SCC) and adenocarcinoma (AC) histological subtypes of NSCLC.

      This is an open label, randomized, multi-center, Phase II study to investigate AXL1717
      compared to docetaxel in patients with squamous cell carcinoma (SCC) or adenocarcinoma (AC)
      of the lung. Patients with previously treated, locally advanced or metastatic SCC or AC
      subtypes of NSCLC in need of additional treatment will be enrolled in the study. Patients
      will be randomized to either AXL1717 or to docetaxel group as monotherapy, in a 3:2 ratio for
      each NSCLC subtype. Patients in AXL1717 group will receive 400 mg AXL1717 twice daily (BID)
      as oral suspension for 21 days per cycle; i.e. daily for up to four cycles unless a dose
      interruption, delay, or reduction is required. Docetaxel will be administered as a standard
      treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the 4-cycle
      study. The primary objective of the study is to compare the rate of progression-free survival
      (PFS) at 12 weeks between patients treated with AXL1717 and patients treated with docetaxel.
      Additional efficacy and safety parameters will be monitored throughout the study. Patients
      treated with AXL1717 who are responding to treatment or remain stable at the end of 4 cycles
      may be offered an extension of treatment with AXL1717.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of progression-free survival (PFS)

Secondary Outcome

 Rate of complete response (CR), partial response (PR), stable disease, (SD), progressive disease (PD), disease control (CR + PR + SD), and objective response (CR + PR)

Condition

Non-small-cell Lung Cancer

Intervention

AXL1717

Study Arms / Comparison Groups

 AXL1717
Description:  AXL1717

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

December 2011

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  informed of the study and have provided written informed consent

          -  At least 18 years of age

          -  Histologically confirmed diagnosis of locally advanced, or metastatic squamous cell
             carcinoma or adenocarcinoma histological subtypes of non-small-cell lung cancer (stage
             IIIB or IV)

          -  For patients with squamous cell histology: previously treated with first-line
             chemotherapy and has had disease progression during or after first-line therapy.

          -  For patients with adenocarcinoma histology: previously treated with one or two lines
             of chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy ≥ 3 months

          -  Measurable disease by RECIST 1.1 criteria

          -  Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil
             count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L
             (transfusions are allowed)

          -  Clinical chemistry values: plasma total bilirubin level ≤ upper limit of the "normal"
             range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤ 5 times if liver
             metastases have been documented) and plasma creatinine ≤ 2.0 x ULN

          -  12-lead ECG with normal tracings

        Exclusion Criteria:

          -  Mixed histology of squamous and non-squamous NSCLC

          -  Ongoing infection or other major recent or ongoing disease that, according to the
             Investigator, poses an unacceptable risk to the patient

          -  Known primary or secondary central nervous system malignancy.

          -  Active or previously treated carcinomatous meningitis

          -  Truly non-measurable disease by RECIST 1.1 criteria, such as patients with one or more
             of the following without any RECIST measurable disease:

               -  Bone lesions

               -  Ascites

               -  Pleural or pericardial effusion

               -  Lymphangitis cutis or pulmonis

               -  Cystic lesions

          -  Grade 3 or higher constipation within the past 28 days or grade 2 constipation within
             the past 14 days before randomization.

          -  Active hepatitis B, active hepatitis C, or known HIV infection

          -  Coexisting uncontrolled medical condition, including active cardiac disease (such as
             unstable angina, myocardial infarction within 6 months, or New York Heart Association
             Class III/IV congestive heart failure), and significant dementia

          -  Hepatic impairment as indicated by abnormalities of transaminases (AST and/or ALT >
             1.5 × ULN or AST and/or ALT > 5 times ULN if liver metastases have been documented)
             and/or increased alkaline phosphatase (> 2.5 × ULN) considered as a result of hepatic
             impairment (and not from bone disease)

          -  History of cancer that has required treatment or been active within the past 5 years,
             other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ

          -  Major surgical procedure within 4 weeks prior to randomization

          -  More than one prior anti-tumor systemic therapy for advanced squamous cell NSCLC, and
             more than two prior lines of chemotherapy for advanced adenocarcinoma NSCLC

          -  Previous use of docetaxel in any line of therapy

          -  Women of child bearing potential (WOCBP) who do not consent to using acceptable
             methods of contraception

          -  Women who are breast-feeding or have a positive pregnancy test at screening

          -  Current participation in any other investigational clinical trial or any
             administration of an investigational agent within 4 weeks of study drug administration

          -  ECOG performance status > 2

          -  Life expectancy < 3 months

          -  Known or suspected hypersensitivity to AXL1717 or docetaxel or to drugs formulated
             with polysorbate 80

          -  Lack of suitability for participation in the trial, for any reason, as judged by the
             Investigator
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Bergqvist, MD, PhD, , 

Location Countries

Belarus

Location Countries

Belarus

Administrative Informations


NCT ID

NCT01561456

Organization ID

AXL-003

Secondary IDs

2011-002007-15

Responsible Party

Sponsor

Study Sponsor

Axelar AB


Study Sponsor

Michael Bergqvist, MD, PhD, Principal Investigator, Uppsala University Hospital, Sweden


Verification Date

December 2013