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

This study has been completed.
Information provided by:
Axelar AB Identifier:
First received: February 3, 2010
Last updated: September 14, 2011
Last verified: September 2011

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.

Condition Intervention Phase
Solid Tumors Drug: AXL1717 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Axelar AB:

Primary Outcome Measures:
  • To define and confirm recommended Phase 2 dose

Enrollment: 49
Study Start Date: April 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AXL1717 Drug: AXL1717
Phase I study with increasing dosage and treatment duration


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01062620

Uppsala University Hospital
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Axelar AB
Principal Investigator: Michael Bergqvist, MD Uppsala University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Bergqvist, Uppsala University Hospital Identifier: NCT01062620     History of Changes
Other Study ID Numbers: AXL-001
Study First Received: February 3, 2010
Last Updated: September 14, 2011 processed this record on August 17, 2017