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A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01062620
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : September 15, 2011
Sponsor:
Information provided by:
Axelar AB

Tracking Information
First Submitted Date  ICMJE February 3, 2010
First Posted Date  ICMJE February 4, 2010
Last Update Posted Date September 15, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2010)
To define and confirm recommended Phase 2 dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer
Official Title  ICMJE A Dose Escalating Phase Ia-b Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer: A Prospective, Single Armed, Open Label, Dose-finding Phase Ia-b Study
Brief Summary

A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer.

The objective is to study the safety and pharmacokinetics of AXL1717 and to define an appropriate Phase 2 dose for further studies. This is the first study in man. The study is not designed to show tumor response.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: AXL1717
Phase I study with increasing dosage and treatment duration
Study Arms  ICMJE Experimental: AXL1717
Intervention: Drug: AXL1717
Publications * Ekman S, Harmenberg J, Frödin JE, Bergström S, Wassberg C, Eksborg S, Larsson O, Axelson M, Jerling M, Abrahmsen L, Hedlund Å, Alvfors C, Ståhl B, Bergqvist M. A novel oral insulin-like growth factor-1 receptor pathway modulator and its implications for patients with non-small cell lung carcinoma: A phase I clinical trial. Acta Oncol. 2016;55(2):140-8. doi: 10.3109/0284186X.2015.1049290. Epub 2015 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2011)
49
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2010)
38
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age.
  2. Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment.
  3. Pharmacological treatment attempt justified
  4. 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
  5. Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
  6. Signed written informed consent.

Exclusion Criteria:

  1. Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
  2. Known malignancy in CNS
  3. Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC).
  4. Pregnancy or lactation
  5. Current participation in any other interventional clinical trial
  6. Performance status > ECOG 2 after optimization of analgesics
  7. Life expectancy less than 3 months
  8. Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
  9. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01062620
Other Study ID Numbers  ICMJE AXL-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Bergqvist, Uppsala University Hospital
Study Sponsor  ICMJE Axelar AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Bergqvist, MD Uppsala University Hospital
PRS Account Axelar AB
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP