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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:

Study Description
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.


Condition or disease Intervention/treatment Phase
Solid Tumors Drug: AXL1717 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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
Study Start Date : April 2008
Primary Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: AXL1717 Drug: AXL1717
Phase I study with increasing dosage and treatment duration


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062620


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