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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: AXL1717

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-75185
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To define and confirm recommended Phase 2 dose

Collaborators and Investigators

• Sponsor: Axelar AB
• Investigators: Principal Investigator: Michael Bergqvist, MD, Uppsala University Hospital

Publications and helpful links

General Publications

• Ekman S, Harmenberg J, Frodin JE, Bergstrom S, Wassberg C, Eksborg S, Larsson O, Axelson M, Jerling M, Abrahmsen L, Hedlund A, Alvfors C, Stahl 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): September 15, 2011
• Last Update Submitted That Met QC Criteria: September 14, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: AXL-001