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NeoplasmsPhase 1NCT02171637

Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

A Phase 1 study testing BIBW 2992 in people with Neoplasms, run by Boehringer Ingelheim.

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

Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992, pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective tumour responses Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
BIBW 2992
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
Nov 2003to Feb 2006
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

  • Male or female patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumors, of types historically known to express EGFR and/or HER2, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
  • Age 18 years or older
  • Life expectancy of at least three (3) months
  • Written informed consent given that is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance score 0, 1, or 2
  • Patients must have resolution of prior chemo-, hormone, immuno-, or radiotherapy-related toxicities to CTC Grade < 1
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  • Patients have to be recovered from previous surgery
  • Paraffin-embedded tumor material must be accessible for analysis of EGFR and HER2-status.
  • The additional 12 patients that were to be recruited at the MTD also had to fulfill the following criterion: Measurable tumor deposits (RECIST: Response Evaluation Criteria in Solid Tumors) by one or more techniques (X-ray, CT, MRI)

Who cannot join

  • Active infectious disease
  • Gastrointestinal disorders that might interfere with the absorption of the study drug or chronic diarrhea
  • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  • Brain metastases requiring therapy as based on clinical symptoms
  • Impaired cardiac left ventricular function with resting ejection fraction CTC Grade ≥ 1
  • Absolute neutrophil count (ANC) less than 1500 / mm3
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  • Platelet count less than 100 000 / mm3
  • Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, SI unit equivalent)
  • Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  • Serum creatinine greater than 1.5 mg / dl (> 132 μmol / L, SI (Systeme International) unit equivalent)
  • Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breast-feeding
  • Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding LHRH agonists, other hormones taken for breast cancer, or bisphosphonates) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
  • Patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • RETREATMENT CRITERIA
  • The patient may be eligible for re-treatment after the previous course finished. The patient will not be eligible if the following criteria are met.
  • Patients with clinical signs of disease progression or if an X-ray, CT or MRI was done and the test showed progressive disease
  • Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course
  • Patients fulfilling any of the Exclusion Criteria as mentioned under exclusion criteria on Day 29 of the previous course
  • Patients not recovered from any dose-limiting toxicity (DLT) 14 days after the last administration of BIBW 2992 in the previous course. Recovery is defined as a return to baseline level or CTC Grade 1, whichever is higher

About this study

Official title: A Phase I Open Label Dose Escalation Study of Once-daily Oral Treatment With BIBW 2992 for 14 Days in Patients With Advanced Solid Tumors

Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992, pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective tumour responses

Conditions
Neoplasms
Being tested
BIBW 2992
Medical subject headings
Neoplasms

What participants receive

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

  • BIBW 2992Drug

    escalating doses

Study groups in NCT02171637
Study groupRoleWhat they receive
BIBW 2992ExperimentalNot described
Receives: Drug: BIBW 2992

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Measured: up to 28 months

  2. Incidence and intensity of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) associated with increasing doses of BIBW 2992

    Measured: up to 28 months

Secondary outcomes (15)

  1. Area under the plasma concentration-time curve (AUC) for different time points

    Measured: up to 384 hours after first drug administration

  2. Predose plasma concentration (Cpre) for different time points

    Measured: Day 8 and 14

  3. Minimum measured plasma concentration (Cmin) for different time points

    Measured: up to 384 hours after first drug administration

  4. Maximum measured plasma concentration (Cmax) for different time points

    Measured: up to 384 hours after first drug administration

  5. Time from dosing to the minimum plasma concentration (tmin) for different time points

    Measured: up to 384 hours after first drug administration

  6. Time from dosing to the maximum plasma concentration (tmax) for different time points

    Measured: up to 384 hours after first drug administration

  7. Terminal half-life (t1/2) for different time points

    Measured: up to 384 hours after first drug administration

  8. Mean residence time after oral administration (MRTpo) for different time points

    Measured: up to 384 hours after first drug administration

  9. Apparent clearance (CL/F) for different time points

    Measured: up to 384 hours after first drug administration

  10. Apparent volume of distribution during the terminal phase (Vz/F) for different time points

    Measured: up to 384 hours after first drug administration

  11. Accumulation ratio (RA)

    Measured: up to 384 hours after first drug administration

  12. Modulation of biomarker (EGFR, p-EGFR, p-MAPK (mitogen-activated protein kinase), p-Akt, Ki-67, p-27KIP1) in skin biopsies prior to administration of BIBW 2992 and at the end of the first treatment period

    Measured: Baseline and day 14

  13. Modulation of biomarker (EGFR, p-EGFR, HER2, p-MAPK, p-Akt, Ki-67, p-27KIP1) in tumor biopsies prior to administration of BIBW 2992 and at the end of the first treatment period in 6 or more patients treated at the MTD

    Measured: Baseline and day 14

  14. Objective tumor responses

    Measured: every 8 weeks up to 28 months

  15. Correlation of EGFR, HER2, estrogen receptor and progesterone receptor immunohistochemical status as based on tumor biopsies or excisions obtained prior to this trial with objective tumor responses

    Measured: up to 28 months

Timeline

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

  1. First posted24 Jun 2014 (estimated)
  2. Study startNov 2003
  3. Primary completionFeb 2006

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02171637
Sponsor's protocol ID
1200.1
Status last verified
Jun 2014
First submitted
20 Jun 2014
Last updated
24 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBW 2992 in people with Neoplasms, run by Boehringer Ingelheim.

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 9 inclusion and 21 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Maximum tolerated dose (MTD) (time frame: up to 28 months). 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 NCT02171637.

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 24 Jun 2014.

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