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

• Sponsor: Axelar AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01062620
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arm: 1

Study Details

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
• Actual Enrollment: 49 participants
• Allocation: N/A
• 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: Apr 1, 2008
• Actual Primary Completion Date: May 1, 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

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

1. Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.

2. 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

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden	SE-75185

Sponsors and Collaborators

• Axelar AB

Investigators

• Principal Investigator: Michael Bergqvist, MD, Uppsala University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01062620
• Other Study ID Numbers: AXL-001
• First Posted: Feb 4, 2010
• Last Update Posted: Sep 15, 2011
• Last Verified: Sep 1, 2011

Study Results

No Results Posted as of Sep 15, 2011