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

NCT01062620 | Completed Phase 1 DMC

• 1 other identifier: AXL-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• To define and confirm recommended Phase 2 dose

Study Arms (1)

AXL1717

EXPERIMENTAL

Drug: AXL1717

Interventions

AXL1717 DRUG

Phase I study with increasing dosage and treatment duration

AXL1717

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment.
• Pharmacological treatment attempt justified
• 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
• Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
• Signed written informed consent.

You may not qualify if:

• Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
• Known malignancy in CNS
• Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC).
• Pregnancy or lactation
• Current participation in any other interventional clinical trial
• Performance status \> ECOG 2 after optimization of analgesics
• Life expectancy less than 3 months
• Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
• Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Sponsors & Collaborators

• Axelar AB: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26161618 DERIVED

MeSH Terms

Interventions

picropodophyllin

Study Officials

• Michael Bergqvist, MD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: April 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

SE (1)