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

NCT01561456 | Completed Phase 2 DMC

• 2 other identifiers: AXL-0032011-002007-15
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 24

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.

Conditions

Non-small-cell Lung Cancer; Squamous Cell Carcinoma; Adenocarcinoma of the Lung

Keywords

non-small-cell lung cancer; squamous cell carcinoma; adenocarcinoma of the lung; IGF-1 inhibitor; docetaxel; AXL1717; NSCLC; SCC; AC

Outcome Measures

Primary Outcomes (1)

• Rate of progression-free survival (PFS)

  12 weeks

Secondary Outcomes (7)

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

  12 weeks

• Median time to disease progression (TTP), time to objective response and time to treatment failure (TTF)

  17 weeks

• Median duration of progression-free-survival (PFS), objective response and disease control

  17 weeks

• 12-week survival

  12 weeks

• 1 year survival

  1 year

Study Arms (2)

AXL1717

EXPERIMENTAL

AXL1717

Drug: AXL1717

Docetaxel

ACTIVE COMPARATOR

Docetaxel

Drug: Docetaxel

Interventions

AXL1717 DRUG

AXL1717 administered as oral suspension at 400 mg twice daily for 21 days per cycle; i.e. daily for up to four cycles

Also known as: small molecule IGF-1 inhibitor

AXL1717

Docetaxel DRUG

Docetaxel administered as a standard treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the 4-cycle study

Also known as: Taxotere

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• lead ECG with normal tracings

You may not qualify if:

• 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

Sponsors & Collaborators

• Axelar AB: lead

Study Sites (24)

State Medical Institution: Republic Scientific Oncology Center

Poselok, Minsk Oblast, 223040, Belarus

Location

Gomel Regional Clinical Oncology Center

Homyel, 246012, Belarus

Location

Minsk City Clinical Oncology Center

Minsk, 220013, Belarus

Location

Vitebsk Regional Clinical Oncology Center

Vitebsk, 210603, Belarus

Location

Semmelweis University; Clinic for Pulmonology

Budapest, 1125, Hungary

Location

University of Debrecen Medical and Health Science Center, Clinic of Pulmonology

Debrecen, 4042, Hungary

Location

Kenezy Gyula County Hospital

Debrecen, 4043, Hungary

Location

Hospital for Thoracic Diseases of Csongrad County Local Government

Deszk, 6772, Hungary

Location

Wladyslaw Bieganski Regional Specialist Hospital

Grudziądz, 86-300, Poland

Location

Maria Sklodowska-Curie Institute of Oncology in Warsaw

Warsaw, 02781, Poland

Location

State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

City Clinical Hospital #1

Novosibirsk, 630047, Russia

Location

Orel Oncology Center

Oryol, 302020, Russia

Location

St. Petersburg State Medical Institution Municipal Clinical Oncology Center

Saint Petersburg, 197022, Russia

Location

State Higher Educational Institution St. Petersburg State Medical University n. a. after I. P. Pavlov under Federal Agency for Healthcare and Social Development, Research Institute of Pulmonology

Saint Petersburg, 197089, Russia

Location

Tula Regional Oncology Center

Tula, 300053, Russia

Location

Sverdlovsk Regional Oncology Center

Yekaterinburg, 620036, Russia

Location

Dnipropetrovsk City Multispecialty Clinical Hospital #4

Dniepropetrovsk, 49102, Ukraine

Location

Public Clinical Treatment and Prophylaxis Institution: Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

Kharkiv, State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences

Kharkiv, 61024, Ukraine

Location

Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center

Kharkiv, 61070, Ukraine

Location

Kyiv City Oncology Hospital

Kyiv, 03115, Ukraine

Location

Lviv State Regional Treatment and Diagnostics Oncology Center

Lviv, 79031, Ukraine

Location

Zakarpattia Regional Clinical Oncology Center

Uzhhorod, 88014, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Adenocarcinoma of Lung

Interventions

picropodophyllin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Adenocarcinoma

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Michael Bergqvist, MD, PhD

  Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 23, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

BE (4); HU (4); UA (7); RU (7); PL (2)