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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: AXL1717

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • University Hospital
  • Uppsala, Sweden
    • KFUE

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 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 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
Other: AXL1717 in combination with Gemcitabine HCL and Carboplatin	Drug: AXL1717; A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Axelar AB
• Investigators: Principal Investigator: Michael Bergqvist, M.D., Ph.D, Uppsala University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 4, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: AXL004