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Solid TumorsPhase 1BARISNCT01349296

BIBF 1120 and RAD001 in Solid Tumors - Phase I

A Phase 1 study testing Everolimus + BIBF 1120 in people with Solid Tumors, run by University of Cologne at 1 site 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

BIBF1120 and RAD001 in solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Everolimus + BIBF 1120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteGermany
Study dates
Jul 2012to May 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven solid tumor disease after failure of standard therapy regimen(s)
  • Age > 18 years.
  • ECOG performance status 0 to 1.
  • Life expectancy of at least 12 weeks.
  • Subjects with at least one measurable (CT or MRI) lesion.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days prior to screening:
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  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count ³ 100,000/μl
  • Total bilirubin within normal limits
  • ALT and AST < 1.5 x upper limit of normal ( or < 2.5 x upper limit of normal in patients with liver involvement)
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
  • Serum creatinine < 1.5 x upper limit of normal or creatinine clearance (CrCl) ≥ 50 ml/min calculated by either Cockcroft-Gault or by 24 hours urine collection
  • More than 14 days since previous chemotherapy, radiotherapy and surgery
  • Negative urine or serum HCG in women of childbearing potential
  • Signed and dated informed consent before the start of specific protocol procedures

Who cannot join

  • Limited number of prior lines of treatment (including surgery and radiotherapy, if part of the standard therapy of the respective tumor entity)
  • Prior treatment with BIBF 1120 or any other VEGFR inhibitor (bevacizumab is allowed)
  • Prior treatment with RAD001 or any other mTOR inhibitor
  • Known hypersensitivity to the trial drugs, to their excipients or to contrast media
  • Chemo-, hormono-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 2 weeks prior to treatment with the trial drugs
  • Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy
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  • Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anticonvulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before trial drug administration) or leptomeningeal metastases (documented by lumbar puncture)
  • History of cardiac disease: congestive heart failure >NYHA class 2; active coronary artery disease (CAD), (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of BIBF1120 or RAD001 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • History of HIV infection or previously seropositive for the virus
  • History of Hepatitis B or/and C or previously seropositive for the Hepatitis B or/and C virus
  • Radiographic evidence of cavitary or necrotic tumors
  • Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
  • Treatment with other investigational drugs or treatment in another clinical trial within the past 30 days before start of therapy or concomitantly with the trial
  • Patients with seizure disorder requiring enzyme-inducing antiepileptics
  • Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous devise) or antiplatelet therapy (except for low-dose therapy with acetylsalicylic acid ≤325mg 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
  • Evidence or history of bleeding diasthesis or thrombosis, and known inherited predisposition to bleeding or thrombosis
  • Proteinuria CTC AE grade 2 or greater
  • Active serious infections
  • Patients undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry
  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
  • 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 vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
  • Pregnancy or breast feeding
  • Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
  • Active alcohol or drug abuse

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of Cologne

    Cologne, North Rhine-Westphalia, 50937

Other trials in Germany

About this study

Official title: BARIS - BIBF1120 and RAD001 in Solid Tumors. A Phase I Trial to Evaluate the Safety and Tolerability of Combined BIBF 1120 and RAD001 in Solid Tumors and to Determine the Maximum Tolerated Dose (MTD) of the Combination

BIBF1120 and RAD001 in solid tumors

Read the detailed description

A phase I trial to evaluate the safety and tolerability of combined BIBF 1120 and RAD001 in solid tumors and to determine the maximum tolerated dose (MTD) of the combination

Conditions
Solid Tumors
Being tested
Everolimus + BIBF 1120
Keywords
Solid Tumors

What participants receive

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

  • Everolimus + BIBF 1120Drug

    Also called Everolimus, RAD001, Afinitor, BIBF 1120

    Dose level 1: 1x 5mg Everolimus/d + 2x 150mg BIBF 1120/d. Dose level 2: 1x 5mg Everolimus/d + 2x 200mg BIBF 1120/d. Dose level 3: 1x 10mg Everolimus/d + 2x 200mg BIBF 1120/d

Study groups in NCT01349296
Study groupRoleWhat they receive
BIBF 1120 + RAD001ExperimentalNot described
Receives: Drug: Everolimus + BIBF 1120

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of RAD001 in combination with BIBF 1120 (150mg bid or 200mg bid) (endpoint: dose-limiting toxicities)

    Documentation an estimation of adverse events

    Measured: Every visit

  2. To evaluate the tolerability of BIBF1120 and RAD001 in combination (endpoints: assessment of adverse events (AEs) according to CTC-AE V4.0)

    Documentation an estimation of adverse events

    Measured: Every visit during the study

Secondary outcomes (4)

  1. To evaluate the clinical efficacy of the combination descriptively (endpoints: RR, progression free survival (PFS), overall survival (OS))

    CT will be done for evaluation of RR and PFS on day 57 and then every 6 weeks until progression.

    For overall survival a telephone call every six months after study is continuation will be done

    Measured: Baseline and every six weeks during the study, after study every 6 months

  2. To analyze individual BIBF1120 pharmacokinetic (PK) parameters at steady-state (ss) of monotherapy and PK parameters of both BIBF1120 and RAD001 at ss of combination

    Blood collection for pharmacokinetic analysis

    Measured: day 14, day 29

  3. To assess changes in tumor vasculature a) early under BIBF1120 monotherapy, b) at ss of BIBF1120 monotherapy and c) at ss of combination therapy using dynamic contrast-enhanced MRI (DCE-MRI) (endpoints: IAUC, Ktrans, Kep, Ve)

    DCE MRI will be done

    Measured: baseline, day 3, day 14, day 29

  4. To correlate the clinical outcome with FGFR1-amplification status (endpoints: see above for clinical parameters)

    Documentation of histology

    Measured: Screening

Timeline

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

  1. First posted6 May 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completionMay 2016

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01349296
Sponsor's protocol ID
BARIS
Acronym
BARIS
Status last verified
May 2016
First submitted
5 May 2011
Last updated
20 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Everolimus + BIBF 1120 in people with Solid Tumors, run by University of Cologne at 1 site 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 16 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: finished, as of the sponsor's last update on 20 May 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 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 determine the maximum tolerated dose (MTD) of RAD001 in combination with BIBF 1120 (150mg bid or 200mg bid) (endpoint: dose-limiting toxicities) (time frame: Every visit). The study lists 2 primary outcomes in all. 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 NCT01349296.

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 20 May 2016.

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