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Colorectal NeoplasmsPhase 2NCT00801294

A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

A Phase 2 study testing BIBF 1120 and BIBW 2992 in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 24 sites in France.

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

The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
BIBF 1120 and BIBW 2992
How many people
46 participants
Where
24 sitesFrance
Study dates
1 Jul 2006to 1 Nov 2007
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years.
  • Signed informed consent.
  • Histologically proven colorectal adenocarcinoma
  • History or presence of metastatic colorectal cancer (stage IV)
  • Measurable (>1 cm) or evaluable tumour deposit (according to RECIST criteria)
  • Documented progression or unacceptable toxicity on the last therapy
Show all 14Show fewer
  • Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
  • Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
  • If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
  • If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
  • Life expectancy of at least 12 weeks.
  • WHO (ECOG) performance status <= 2, <= 1 if age > 75 years.
  • Adequate hepatic function
  • Adequate renal function

Who cannot join

  • Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
  • Treatment with standard chemotherapy or cetuximab within the last 14 days
  • Treatment with bevacizumab within the last 28 days
  • History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
  • Significant cardiovascular diseases
Show all 9Show fewer
  • History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
  • Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
  • Pregnancy or breast-feeding

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • 1239.2.3305A clinique Saint Jean

    Lyon

  • 1239.2.3305B Cabinet Médical

    Lyon

  • 1239.2.3301A Hôpital Saint Antoine

    Paris

  • 1239.2.3301B Hôpital Saint Antoine

    Paris

  • 1239.2.3301C Hôpital Saint Antoine

    Paris

  • 1239.2.3301D Hôpital Saint Antoine

    Paris

  • 1239.2.3301E Hôpital Saint Antoine

    Paris

  • 1239.2.3301F Hôpital Saint Antoine

    Paris

  • 1239.2.3301G Hôpital Saint Antoine

    Paris

  • 1239.2.3301H Hôpital Saint Antoine

    Paris

  • 1239.2.3301I Hôpital Saint Antoine

    Paris

  • 1239.2.3301J Hôpital Saint Antoine

    Paris

  • 1239.2.3301K Hôpital Saint Antoine

    Paris

  • 1239.2.3302A Hôpital Tenon

    Paris

  • 1239.2.3302B Hôpital Tenon

    Paris

  • 1239.2.3304A Hôpital Robert Debré

    Reims

  • 1239.2.3304B Hôpital Robert Debré

    Reims

  • 1239.2.3304C Hôpital Robert Debré

    Reims

  • 1239.2.3303A Institut Gustave Roussy

    Villejuif

  • 1239.2.3303B Institut Gustave Roussy

    Villejuif

  • 1239.2.3303C Institut Gustave Roussy

    Villejuif

  • 1239.2.3303D Institut Gustave Roussy

    Villejuif

  • 1239.2.3303E Institut Gustave Roussy

    Villejuif

  • 1239.2.3303F Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.

Being tested
BIBF 1120 and BIBW 2992
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • BIBF 1120 and BIBW 2992Drug

What is being measured

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

  1. The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks

    Measured: every 4 weeks

  2. PFS

    Measured: 16 weeks

Secondary outcomes (5)

  1. Progression-free survival (based on the RECIST criteria)

    Measured: 66 Weeks

  2. Overall survival

    Measured: 66 Weeks

  3. The incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0)

    Measured: 66 Weeks

  4. Changes in safety laboratory parameters

    Measured: 66 Weeks

  5. Effectiveness of dose reduction guidelines in managing adverse events

    Measured: 66 Weeks

Timeline

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

  1. First posted3 Dec 2008 (estimated)
  2. Study start1 Jul 2006
  3. Primary completion1 Nov 2007

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
Intervention model
Parallel groups
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801294
Sponsor's protocol ID
1239.2
Other IDs
EudraCT 2006-000893-56
Status last verified
Dec 2017
First submitted
2 Dec 2008
Last updated
29 Dec 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF 1120 and BIBW 2992 in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 24 sites in France.

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 14 inclusion and 9 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. 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 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?

The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks (time frame: every 4 weeks). 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 NCT00801294.

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 29 Dec 2017.

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