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NeoplasmsPhase 1NCT02171702

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

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

The primary objective of the study was to identify the maximum tolerated dose and to evaluate safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992. 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
53 participants
Where
No sites listed yet
Study dates
Nov 2004to Mar 2007
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 tumours, 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 preferably patients with breast, colorectal or prostate cancer
  • Age 18 years or older
  • Life expectancy of at least three (3) months
  • Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2
  • Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC <= Grade 1
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  • Patients must be recovered from previous surgery
  • The 12 additional patients recruited at the MTD must also meet the following criteria:
  • Measurable tumour deposits (RECIST) by one or more techniques (X-ray, CT, MRI) and/or recognized tumour markers such as prostate-specific antigen prostate cancer) or cancer antigen 125 (Ovarian cancer)

Who cannot join

  • Active infectious disease
  • Gastrointestinal disorders that may 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
  • Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least eight (8) weeks, no history of cerebral edema or bleeding in the past eight (8) weeks and no requirement for steroids or anti-epileptic therapy
  • 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, Système Internationale (SI) unit equivalent)
  • Aspartate amino transferase (AST) 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 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 Luteinizing Hormone-Releasing Hormone agonists, or other hormones taken for breast cancer, or bisphosphonates), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study
  • Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (8 weeks for trastuzumab)
  • Patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • A patient may be eligible for re-treatment after the previous course is finished. A patient will not be eligible if any of the following conditions are met.
  • Patients with clinical signs of disease progression or if latest X-ray, CT or MRI reveals Progressive Disease
  • Cardiac left ventricular function CTC >= Grade 2 at any time during the previous course
  • Patients fulfilling any of the Exclusion Criteria listed before as determined before treatment on Day 28, R5 of the previous course
  • Patient not recovered from any dose-limiting toxicity 14 days after the last administration of BIBW 2992 in the previous course. Recovery is defined as 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 28 Days in Patients With Advanced Solid Tumours

The primary objective of the study was to identify the maximum tolerated dose and to evaluate safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992.

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

Study groups in NCT02171702
Study groupRoleWhat they receive
BIBW 2992Experimentaldose escalation
Receives: Drug: BIBW 2992
BIBW 2992, fastedExperimentalfood effect part: maximum tolerated dose of BIBW 2992
Receives: Drug: BIBW 2992
BIBW 2992, fedExperimentalfood effect part: maximum tolerated dose of BIBW 2992
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) of BIBW 2992

    Measured: up to 24 weeks

  2. Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 3) associated with increasing doses of BIBW 2992

    Measured: up to 28 weeks

Secondary outcomes (15)

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

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  2. Percentage of AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  3. predose plasma concentration

    Measured: predose on days 8, 15, 22 and 27

  4. Plasma concentration

    Measured: 24 hours after drug administration on the first (C24,1) and the Day 27 dose (C24,27)

  5. Maximum measured plasma concentration (Cmax) for several time points

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

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

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  7. terminal half-life (t1/2(ss))

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  8. mean residence time after oral administration (MRTpo(ss))

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  9. apparent clearance (CL/F(ss))

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  10. apparent volume of distribution during the terminal phase (Vz/F(ss))

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  11. Accumulation ratio between Day 1 and Day 27 with respect to Cmax (RA1) and AUC (RA2)

    Measured: up to 648 hours after first drug administration, pre-dose on day 15 and 28

  12. Modulation of biomarker (EGFR, p-EGFR, p-MAPK, p-Akt, Ki 67, p-27KIP1) in skin biopsies

    Measured: Baseline and day 28 of the first treatment period

  13. Modulation of biomarker (EGFR, p-EGFR, HER2 (Class I Tyrosine Kinase Receptor), p-MAPK (mitogen-activated protein kinase), p-Akt, Ki 67, p-27KIP1) in tumour biopsies in six or more patients treated at the MTD

    Measured: Baseline and day 28 of the first treatment period

  14. Objective tumour response

    Measured: up to 25 weeks

  15. Correlation of EGFR, HER2, estrogen receptor (ER) and progesterone receptor (PrR) immunohistochemical status as based on tumour biopsies, or excisions obtained prior to this study, with objective tumour responses

    Measured: up to 25 weeks

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 2004
  3. Primary completionMar 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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02171702
Sponsor's protocol ID
1200.3
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) of BIBW 2992 (time frame: up to 24 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 NCT02171702.

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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