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

Axelar AB

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: AXL1717

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466647

AXL004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

AXL1717 in combination with Gemcitabine HCL and Carboplatin

Other group

Description:

AXL1717 in combination with Gemcitabine HCL and Carboplatin

Treatment:

Drug: AXL1717