Clinical trial NCT01466647: A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Axelar AB
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin
timeFrame: End of two cycles, i.e. 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: KFUE
city: Uppsala
country: Sweden
facility: University Hospital
Study officials:
affiliation: Uppsala University Hospital, Sweden
name: Michael Bergqvist, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: