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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axelar AB
ClinicalTrials.gov Identifier:
NCT01466647
First received: October 21, 2011
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: AXL1717
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Axelar AB:

Primary Outcome Measures:
  • Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin [ Time Frame: End of two cycles, i.e. 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AXL1717 in combination with Gemcitabine HCL and Carboplatin
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466647

Locations
Sweden
KFUE
Uppsala, Sweden
University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Axelar AB
Investigators
Principal Investigator: Michael Bergqvist, M.D., Ph.D Uppsala University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Axelar AB
ClinicalTrials.gov Identifier: NCT01466647     History of Changes
Other Study ID Numbers: AXL004
Study First Received: October 21, 2011
Last Updated: November 9, 2012
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Axelar AB:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014