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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062620
• Other study ID #: AXL-001
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2010
• Last updated: September 14, 2011
• Start date: April 2008

Study information

• Verified date: September 2011
• Source: Axelar AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Product Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• AXL1717
Phase I study with increasing dosage and treatment duration

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Axelar AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define and confirm recommended Phase 2 dose			No