A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)

November 9, 2012 updated by: Axelar AB

A Phase I Pilot Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin in Previously Untreated, Locally Advanced, or Metastatic Squamous Non-small-cell Lung Cancer

This is a open single-center, explorative, Phase I pilot dose finding study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open single-center, explorative, Phase I pilot study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin. Patients will be treated within the study for 2 treatment cycles of 3 weeks each. Survival data will be obtained. Tumor assessment will be conducted at baseline and then at the end of the study period. Concomitant supportive therapies will be allowed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • Uppsala, Sweden
        • University Hospital
      • Uppsala, Sweden
        • KFUE

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)

  3. Preserved major organ functions, i.e:

    • B-Leukocyte count ≥ 3.0 x 109/L
    • B-Neutrophil count ≥ 1.5 x 109/L
    • B-Platelet count ≥ 75 x109/L
    • B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
    • P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference)range
    • P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
    • P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
    • 12-lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention
  4. Signed written informed consent.

Exclusion Criteria:

  • The presence of any of the following criteria will exclude the patient from participating in the study:

    • Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
    • Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal management of constipation.)
    • Known malignancy in Central Nervous System (CNS)
    • Disease and dementia and neuropathy grade more than 1
    • Other active malignancy during the previous 3 years
    • Major surgical procedure within 4 weeks
    • Prior anti-tumor therapy apart from radiation therapy
    • Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP include any female who has experienced menarche and who is not postmenopausal. Post menopause is defined as: Amenorrhea ≥ 12 consecutive months without another cause
    • Pregnancy or lactation
    • Current participation in any other interventional clinical trial
    • Performance status > ECOG 2 after optimization of analgesics
    • Life expectancy less than 3 months
    • Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
    • Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: AXL1717 in combination with Gemcitabine HCL and Carboplatin
Drug: AXL1717
A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin
Time Frame: End of two cycles, i.e. 6 weeks
A dose finding pilot study to evaluate safety and pharmacokinetics in combination with Gemcitabine HCL and Carboplatin during two treatment cycles, i.e. 6 weeks.
End of two cycles, i.e. 6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axelar AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Bergqvist, M.D., Ph.D, Uppsala University Hospital, Sweden

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AXL004

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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