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

NCT01466647 | Completed Phase 1 DMC

• 1 other identifier: AXL004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AXL1717 in combination with Gemcitabine HCL and Carboplatin

OTHER

AXL1717 in combination with Gemcitabine HCL and Carboplatin

Drug: AXL1717

Interventions

AXL1717 DRUG

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

AXL1717 in combination with Gemcitabine HCL and Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• 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)
• 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
• lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention
• Signed written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axelar AB: lead

Study Sites (2)

KFUE

Uppsala, Sweden

Location

University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

picropodophyllin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Bergqvist, M.D., Ph.D

  Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 8, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

SE (2)