A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I Pilot Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin in Previously Untreated, Locally Advanced, or Metastatic Squamous Non-small-cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466647
• Other study ID #: AXL004
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2011
• Last updated: November 9, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Axelar AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review BoardSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical Trial Summary

This is a open single-center, explorative, Phase I pilot dose finding study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin.

Description:

Open single-center, explorative, Phase I pilot study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin. Patients will be treated within the study for 2 treatment cycles of 3 weeks each. Survival data will be obtained. Tumor assessment will be conducted at baseline and then at the end of the study period. Concomitant supportive therapies will be allowed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age.

2. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)

3. 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

• 12-lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention

4. Signed written informed consent.

Exclusion Criteria:

• The presence of any of the following criteria will exclude the patient from participating in the study:

• Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient

• Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to = grade 1 with optimal management of constipation.)

• Known malignancy in Central Nervous System (CNS)

• Disease and dementia and neuropathy grade more than 1

• Other active malignancy during the previous 3 years

• Major surgical procedure within 4 weeks

• Prior anti-tumor therapy apart from radiation therapy

• Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP include any female who has experienced menarche and who is not postmenopausal. Post menopause is defined as: Amenorrhea = 12 consecutive months without another cause

• 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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• AXL1717
A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods

Locations

Country	Name	City	State
Sweden	KFUE	Uppsala
Sweden	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	Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin	A dose finding pilot study to evaluate safety and pharmacokinetics in combination with Gemcitabine HCL and Carboplatin during two treatment cycles, i.e. 6 weeks.	End of two cycles, i.e. 6 weeks	No