Non-small-cell Lung CancerPhase 2NCT01561456
Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung
A Phase 2 study testing AXL1717 and Docetaxel in people with Non-small-cell Lung Cancer and Squamous Cell Carcinoma, run by Axelar AB at 24 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer, Squamous Cell Carcinoma, Adenocarcinoma of the Lung
- What is being tested?
- AXL1717 and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 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
- 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
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- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Russia7 sites
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncology Center
Chelyabinsk, 454087
City Clinical Hospital #1
Novosibirsk, 630047
Orel Oncology Center
Oryol, 302020
St. Petersburg State Medical Institution Municipal Clinical Oncology Center
Saint Petersburg, 197022
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
Tula Regional Oncology Center
Tula, 300053
Sverdlovsk Regional Oncology Center
Yekaterinburg, 620036
Ukraine7 sites
Dnipropetrovsk City Multispecialty Clinical Hospital #4
Dniepropetrovsk, 49102
Public Clinical Treatment and Prophylaxis Institution: Donetsk Regional Antitumor Center
Donetsk, 83092
Kharkiv, State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences
Kharkiv, 61024
Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center
Kharkiv, 61070
Kyiv City Oncology Hospital
Kyiv, 03115
Lviv State Regional Treatment and Diagnostics Oncology Center
Lviv, 79031
Zakarpattia Regional Clinical Oncology Center
Uzhhorod, 88014
Belarus4 sites
Gomel Regional Clinical Oncology Center
Homyel, 246012
Minsk City Clinical Oncology Center
Minsk, 220013
State Medical Institution: Republic Scientific Oncology Center
Poselok, Minsk Oblast, 223040
Vitebsk Regional Clinical Oncology Center
Vitebsk, 210603
Hungary4 sites
Semmelweis University; Clinic for Pulmonology
Budapest, 1125
University of Debrecen Medical and Health Science Center, Clinic of Pulmonology
Debrecen, 4042
Kenezy Gyula County Hospital
Debrecen, 4043
Hospital for Thoracic Diseases of Csongrad County Local Government
Deszk, 6772
Poland2 sites
Wladyslaw Bieganski Regional Specialist Hospital
Grudziądz, 86-300
Maria Sklodowska-Curie Institute of Oncology in Warsaw
Warsaw, 02781
About this study
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
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.
Read the 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.
- Being tested
- AXL1717, Docetaxel
- Keywords
- non-small-cell lung cancer, squamous cell carcinoma, adenocarcinoma of the lung, IGF-1 inhibitor, docetaxel, AXL1717, NSCLC, SCC, AC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXL1717Drug
Also called small molecule IGF-1 inhibitor
AXL1717 administered as oral suspension at 400 mg twice daily for 21 days per cycle; i.e. daily for up to four cycles
DocetaxelDrug
Also called Taxotere
Docetaxel administered as a standard treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the 4-cycle study
| Study group | Role | What they receive |
|---|---|---|
| AXL1717 | Experimental | AXL1717 Receives: Drug: AXL1717 |
| Docetaxel | Active comparator | Docetaxel Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression-free survival (PFS)
Measured: 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)
Measured: 12 weeks
Median time to disease progression (TTP), time to objective response and time to treatment failure (TTF)
Measured: 17 weeks
Median duration of progression-free-survival (PFS), objective response and disease control
Measured: 17 weeks
12-week survival
Measured: 12 weeks
1 year survival
Measured: 1 year
Investigational product toxicity profile
Measured: 17 weeks
Overall survival
Measured: time from randomization to death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axelar AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Bergqvist, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561456
- Sponsor's protocol ID
- AXL-003
- Other IDs
- 2011-002007-15
- Status last verified
- Dec 2013
- First submitted
- 5 Mar 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01561456
- Acronym / sponsor ID
- AXL-003
- Keywords
- non-small-cell lung cancer, squamous cell carcinoma, adenocarcinoma of the lung, IGF-1 inhibitor, docetaxel, AXL1717, NSCLC, SCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Axelar ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXL1717 | Experimental | Drug: AXL1717AXL1717 |
| Docetaxel | Active comparator | Drug: DocetaxelDocetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXL1717Also: small molecule IGF-1 inhibitorAXL1717 administered as oral suspension at 400 mg twice daily for 21 days per cycle; i.e. daily for up to four cycles | Drug | AXL1717 |
| DocetaxelAlso: TaxotereDocetaxel administered as a standard treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the 4-cycle study | Drug | Docetaxel |
Primary outcome
Rate of progression-free survival (PFS)
Time frame: 12 weeks
7 secondary outcomes
Rate of complete response (CR), partial response (PR), stable disease, (SD), progressive disease (PD), disease control (CR + PR + SD), and objective response (CR + PR)
Time frame: 12 weeks
Median time to disease progression (TTP), time to objective response and time to treatment failure (TTF)
Time frame: 17 weeks
Median duration of progression-free-survival (PFS), objective response and disease control
Time frame: 17 weeks
12-week survival
Time frame: 12 weeks
1 year survival
Time frame: 1 year
Investigational product toxicity profile
Time frame: 17 weeks
Overall survival
Time frame: time from randomization to death from any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bergqvist, MD, PhD principal investigator
Uppsala University Hospital
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXL1717 and Docetaxel in people with Non-small-cell Lung Cancer and Squamous Cell Carcinoma, run by Axelar AB at 24 sites in 5 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 25 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 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia, Ukraine, Belarus, Hungary, Poland. 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 phase mean?
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?
Rate of progression-free survival (PFS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2013.