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Small Cell Lung CancerPhase 2NCT02152059

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

A Phase 2 study testing BIBF1120 in people with Small Cell Lung Cancer and Platinum-sensitive, run by AHS Cancer Control Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer, Platinum-sensitive
What is being tested?
BIBF1120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jul 2014to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • All patients must have a blood pressure of 150/90 mm Hg or less at the time of enrollment. Patients who have been on anti-hypertensives will be eligible if their blood pressure is less than 150/90 mm Hg on enrollment with no increase of their anti-hypertensive medications for the 2 weeks prior to enrollment.
  • Signed and dated written informed consent prior to enrollment in the study in accordance with ICH-GCP guidelines and to the local legislation.

Who cannot join

  • 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.
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  • 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.
  • Radiographic evidence of cavitary or necrotic tumors.
  • Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels. As small cell lung cancer is often presented as a mediastinal mass, compression of mediastinal blood vessels will be allowed.
  • Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day).
  • Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
  • History of clinically significant haemorrhagic or thromboembolic event in the past 6 months.
  • Proteinuria CTCAE grade 2 or greater.
  • Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix.
  • Active serious infections, in particular if requiring systemic antibiotic or antimicrobial therapy.
  • Active or chronic hepatitis C and/or B infection.
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomised partner for participating females, condoms for participating males) during the trial and for at least 3 months after end of active therapy. Patients who are pregnant and/or lactating are not eligible.
  • Active alcohol or drug abuse.
  • Significant weight loss (> 10% of body weight) within past 6 months prior to inclusion into the trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

Official title: A Phase II Study of BIBF1120 in Recurrent and Platinum-Sensitive Small Cell Lung Cancer (SCLC)

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.
Read the detailed description

This study is being done to evaluate the effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients.

Primary Objectives:

  • To investigate the efficacy and safety of a novel VEGFR-2 and FGFR-1 targeting agent, BIBF1120, in previously treated, platinum-sensitive small cell lung cancer patients.

Secondary Objectives:

  • To correlate response to the apoptotic biomarkers, Bcl-XL/Bcl-2 and FDGR-1 amplification.
  • To correlate response with baseline FLT-PET SUV uptake and change in FLT-PET SUV uptake.

All eligible patients will be treated with 200 mg bid of BIBF1120 daily and 21 days will be considered as one cycle

Being tested
BIBF1120
Keywords
Small cell lung cancer, BIBF1120, nintedanib, platinum-sensitive
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBF1120Drug

    Also called Nintedanib

    BIBF1120 is a VEGFR, FGFR and PDGFR inhibitor

Study groups in NCT02152059
Study groupRoleWhat they receive
BIBF1120ExperimentalBIBF1120 200 mg twice daily continuously
Receives: Drug: BIBF1120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate

    Measured: 90 days

Secondary outcomes (1)

  1. Disease response rate

    Measured: every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: contract issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02152059
Sponsor's protocol ID
BIBF-SCLC-001
Status last verified
Jul 2016
First submitted
29 May 2014
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF1120 in people with Small Cell Lung Cancer and Platinum-sensitive, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02152059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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