A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

NCT02152059 | Withdrawn Phase 2

• 1 other identifier: BIBF-SCLC-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be more effective and better tolerated than standard therapy. The purpose of this study is to:

• Find out the proportion of patients with their small small cell lung cancer controlled for at least 90 days after treatment with BIBF1120
• Compare the response rate, survival and side effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients
• Identify a group of patients who will benefit the most from BIBF1120 In this study, patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21 days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if patients do not tolerate it well or if the doctors are concerned about the side effects of BIBF1120 on individual patients.

Conditions

Small Cell Lung Cancer; Platinum-sensitive

Keywords

Small cell lung cancer; BIBF1120; nintedanib; platinum-sensitive

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  90 days

Secondary Outcomes (1)

• Disease response rate

  every 6 weeks

Study Arms (1)

BIBF1120

EXPERIMENTAL

BIBF1120 200 mg twice daily continuously

Drug: BIBF1120

Interventions

BIBF1120 DRUG

BIBF1120 is a VEGFR, FGFR and PDGFR inhibitor

Also known as: Nintedanib

BIBF1120

Eligibility Criteria

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

You may qualify if:

• Age \> 18
• Recurrent and platinum-sensitive small cell lung cancer (SCLC): defined as those patients with SCLC recurrence at least 3 months from the last dose of platinum-based chemotherapy. Definition of platinum-sensitive disease is patient with at least 3 months of progression-free duration after finishing first-line platinum-based chemotherapy.
• Histological diagnosis of small cell lung cancer (including Oat cell carcinoma, small cell neuroendocrine tumor). Patients with archival tumor samples will be collected for further translational studies. For those who have no archival tumor samples, without due harm, a fresh biopsy can be obtained.
• As progression-free survival (PFS) or PFS rate is the endpoint, all patients enrolled must have measurable (per RECIST 1.1 Criteria) radiological progression of disease on radiological investigations.
• ECOG performance status of 0-2
• Adequate hematological function defined as hemoglobin \> 90 g/L, ANC \> 1500/uL and platelets \> 100, 000/uL.
• Adequate renal function defined as creatinine \< 1.5 x ULN or creatinine clearance \> 45 mL/min (Cockcroft-Gault).
• Adequate liver function defined as AST/ALT \< 1.5 x ULN or \< 2.5 x ULN in the presence of liver metastases and total bilirubin \< 1.5 x ULN.
• INR/PTT \< 1.5 x ULN
• Left ventricular function by echocardiogram \> institutional lower limit of normal.
• Women of childbearing potential and all must use adequate birth control. A serum pregnancy test must be performed within 72 hours from enrollment for all eligible women of childbearing potential.
• The absence of any significant psychiatric and medical condition that will potentially affect compliance to therapy or will be adversely affected by the experimental therapy.
• Able to swallow oral medication.
• Life expectancy of at least 12 weeks.
• All patients enrolled must have at least one prior platinum-based chemotherapy regimen in either the limited staged or extensive staged setting.

You may not qualify if:

• Symptomatic, untreated brain metastasis. Patients with asymptomatic brain metastasis defined as those with no CNS symptoms, no concurrent significant edema on CT or MRI of the brain and no concurrent corticosteroid therapy will be eligible. Those with leptomeningeal disease will NEVER be eligible due to overall poor prognosis. Patients who have treated brain metastasis without concurrent corticosteroid and anti-convulsant therapy and without progression on CT or MRI scan of the brain for at least 60 days will be eligible
• Symptoms of congestive heart failure, myocardial infarction or angina within 6 months.
• Previous allergy to VEGR or FGF tyrosine kinase inhibitor.
• Current therapeutic coumadin treatment.
• History of pulmonary embolism, deep vein thrombosis within the past 1 year. Patients with any prior history of peripheral arterial thrombosis are not eligible.
• History of hemoptysis of more than 5 mL per episode or more than 10 mL/week in total within the past 3 months.
• History of bleeding disorder.
• Surgery, hormonal therapy, chemotherapy, radiation therapy or other investigational agents within 28 days of enrollment, with the exception of low dose palliative RT (20 Gy or less involving \< 10% bone marrow).
• History of recent gastrointestinal bleeding, obstruction or perforation of malabsorption syndrome.
• History of QT c \> 480 ms on ECG or hsitory of cardiac arrhythmia or treatment with anti-arrhythmic except for atrial fibrillation or any history of second- or third-degree heart block.
• Diagnosis of HIV infection or AIDS.
• Diagnosis of interstitial lung disease.
• Radiotherapy (except extremities) within the past 2 months prior to baseline imaging.
• Persistence of clinically relevant therapy-related toxicity from previous chemotherapy and/or radiotherapy.
• Leptomeningeal disease.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

nintedanib

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

• Quincy Chu, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CA (1)