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

This study has been completed.
Sponsor:
Information provided by:
Axelar AB
ClinicalTrials.gov Identifier:
NCT01062620
First received: February 3, 2010
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Axelar AB:

Primary Outcome Measures:
  • To define and confirm recommended Phase 2 dose [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062620

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

No publications provided

Responsible Party: Michael Bergqvist, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01062620     History of Changes
Other Study ID Numbers: AXL-001
Study First Received: February 3, 2010
Last Updated: September 14, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Product Agency

ClinicalTrials.gov processed this record on July 22, 2014