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Carcinoma, Non-Small-Cell LungPhase 1VENUS-2NCT01683682

An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV (VENUS-2)

A Phase 1 study testing BIBF 1120, Vinorelbine and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Aktion Bronchialkarzinom e.V. at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV). Read more about this study

Who is it for?
Ages 71 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
BIBF 1120, Vinorelbine and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesGermany
Study dates
Apr 2013to Jan 2015
Phase
Phase 1
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 71 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histological confirmed Non-Small-Cell lung cancer (NSCLC)
  • Tumor stage IV (UICC 7th Version)
  • ECOG <2
  • Age > 70 years
  • No previous chemotherapy for stage IV NSCLC (UICC 7th Version)
  • Adjuvant or neoadjuvant chemotherapy for NSCLC must be completed at least one year prior to study enrolment (from end of chemotherapy)
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  • Patients with prior radiation therapy may be eligible for this study if they meet the following guidelines:
  • Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), but should have been limited and must not have included whole pelvis radiation.
  • Patients must have recovered from the toxic effects of the treatment prior to study enrolment (except for alopecia).
  • Prior thoracic radiotherapy must be completed 30 days before study enrolment.
  • Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumour progression has been documented in these lesions since the end of radiation therapy.
  • Palliative extrathoracic radiotherapy to pre-existing lesions may continue on study; however, these lesions may not be included as sites of measurable disease.
  • Adequate haematological laboratory parameters:
  • Haemoglobin ≥9 g/dl
  • WBC ≥3.000/µl
  • Platelets ≥ 100.000/µl
  • Neutrophil count > 1,500/µl
  • Adequate renal laboratory parameters
  • Creatinine ≤1,9 mg/dl
  • Creatinine Clearance > 45 ml/min
  • Adequate hepatic function
  • Total bilirubin within normal range
  • Total bilirubin < 1.5 x ULN (patients with liver metastasis)
  • ALT < 1.5 x ULN
  • ALT < 2.5 x ULN (patients with liver metastasis)
  • AST < 1.5 x ULN
  • AST < 2.5 x ULN (patients with liver metastasis)
  • Alk. phosphatase < 3 x ULN
  • LDH < 5 x ULN ULN = Upper Limit Of Normal (ULN)
  • Other lab parameters:
  • Proteinuria < CTCAE grade 2
  • Prothrombin time and/or partial thromboplastin time < 50 % deviation from normal limits
  • Informed consent, personally signed and dated to participate in the study
  • Male patients enrolled in this trial must use adequate barrier birth control measures during the course of treatment and for at least 3 months after the last administration of study therapy
  • Life expectancy at least 3 months

Who cannot join

  • Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
  • Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy
  • Serious, non-healing wound, ulcer or bone fracture or major injuries and/or surgery within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Known hypersensitivity to the trial drugs or their excipients.
  • History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
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  • Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
  • Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure >NYHA II)
  • Known inherited predisposition to bleeds or to thrombosis.
  • Patient with brain metastases that are symptomatic and/or require therapy.
  • Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)
  • History of major thrombotic events or clinically relevant major bleeding event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis below the joint space of the knee)
  • Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  • Active alcohol or drug abuse.
  • Men who are sexually active and unwilling to use a medically acceptable method of contraception
  • Leptomeningeal disease
  • Radiographic evidence of cavitary or necrotic tumours
  • Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Krankenhaus Großhansdorf

    Großhansdorf, D-22927

  • Klinikum Kassel GmbH

    Kassel, D-34125

Other trials in Germany

About this study

Official title: An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV

To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV).

Read the detailed description

Patients older than 70 years could be enrolled in this clinical trial. The trial is being carried out in two trial centres in Germany.

For the planned sample size it is assumed that two different dosage groups are needed with 6 patients on each dosage group with the option to deescalate the first dosage. Altogether this leads to an estimated sample size of maximal 18 patients.

  • Duration of treatment/patient: up to 6 month
  • Follow Up: at least 6 month
Being tested
BIBF 1120, Vinorelbine, Carboplatin
Keywords
Non-Small Lung Cancer, NSCLC Stage IV
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • BIBF 1120Drug

    2 x 150 mg capsules, oral, daily (Start dose)

  • VinorelbineDrug

    25 mg/m2 i.v. on day 1 and 8 (three-week cycle)

  • CarboplatinDrug

    AUC 5 i.v. on day 1 (three-week cycle)

Study groups in NCT01683682
Study groupRoleWhat they receive
BIBF 1120, Vinorelbine, CarboplatinExperimentalTo determine the 'Maximum Toleraetd Dose', dose escalation for BIBF 1120 will be conducted following the 3 + 3 design. A cohort of three patients will be treated at the starting dose level 150mg bid and observed until the end of the first cycle. Under certain conditions the dose level will be escalated to 200mg bid in a second cohort.
Receives: Drug: BIBF 1120; Drug: Vinorelbine; Drug: Carboplatin

What is being measured

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

  1. To investigate the maximum tolerated dose of BIBF 1120

    Measured: Cycle 1 day 1, day 8, day 15; Cycle 2 day 1, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84

Secondary outcomes (2)

  1. Incidence of adverse events

    Measured: Cycle 1 day 1, day 8, day 15; Cycle 2 day 1, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84

  2. Response Rate

    Measured: Day 43 (prior start of cycle 3), day 84

Timeline

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

  1. First posted12 Sep 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2015

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683682
Sponsor's protocol ID
ABC-2011-NSCLC-04
Other IDs
2011-002141-36
Acronym
VENUS-2
Status last verified
Jan 2015
First submitted
28 Aug 2012
Last updated
26 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBF 1120, Vinorelbine and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Aktion Bronchialkarzinom e.V. at 2 sites in Germany.

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 35 inclusion and 19 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: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To investigate the maximum tolerated dose of BIBF 1120 (time frame: Cycle 1 day 1, day 8, day 15; Cycle 2 day 1, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84). 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 NCT01683682.

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 26 Jan 2015.

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