NeoplasmsPhase 1NCT02171728
Dose Escalation Study of Continuous Once-daily 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.
Trial summary
Investigation of maximum tolerated dose (MTD), 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Sep 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 (Human Epidermal Growth Factor Receptor), 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 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 tumor deposits (RECIST) by one or more techniques (X-ray, CT, MRI) and/or recognized tumor markers such as prostate-specific antigen (PSA) (prostate cancer) or cancer antigen (CA) 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, 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, Système Internationale 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 (LHRH) agonists, or 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
- Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (eight 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 disease progression
- Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course
- Patients fulfilling any of the Exclusion Criteria (except criterion 5) listed before as determined
- On Day 28 of treatment period 1 or on Visit R1 of the current course when patient is entering the repeated treatment period (treatment period 2),
- On Visit R5 of the previous course or on Visit R1/C1 of the current course when patient is in repeated treatment period (treatment courses 3 to 6) or when entering continuous treatment period (treatment course 7), or
- On Visit C3 of the previous course or Visit C1 of the current course when patient is in continuous treatment period (treatment courses 8 to final discontinuation)
- Patient 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 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 Continuous Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors
Investigation of maximum tolerated dose (MTD), 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 group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | dose escalation Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of BIBW 2992
Measured: up to 168 days
Incidence and intensity of Adverse Events according to Common Terminology Criteria (CTC version 3)
Measured: up to 23 months
Secondary outcomes (12)
Area under the plasma concentration-time curve (AUC) for several time points
Measured: up to 28 days
Predose plasma concentration
Measured: Predose on day 8, 15, 22 and 27
Plasma concentration at 24 h following the first (C24,1) and the Day 27 dose (C24,27)
Measured: 24 hours after drug administration on day 24 and 27
Plasma concentration at 3 h following the first dose (C3,1)
Measured: 3 hours after the first dose on day 1
Maximum measured plasma concentration at steady state on Day 27 (Cmax,ss)
Measured: up to 24 hours after drug administration on day 27
Time from dosing to the maximum plasma concentration at steady state on Day 27 (tmax,ss)
Measured: up to 24 hours after drug administration on day 27
Terminal half-life at steady state (t1/2,ss)
Measured: up to 28 days
Mean residence time after oral administration at steady state (MRTpo,ss)
Measured: up to 28 days
Apparent clearance at steady state (CL/F,ss)
Measured: up to 28 days
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Measured: up to 28 days
Objective tumor responses
Measured: up to 23 months
Correlation of EGFR (epidermal growth factor receptor), HER2, estrogen receptor (ER) and progesterone receptor (PrR) immunohistochemical status as based on tumor biopsies, or excisions obtained prior to this trial, with objective tumor responses
Measured: up to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startNov 2004
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171728
- Sponsor's protocol ID
- 1200.4
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Dose Escalation Study of Continuous Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02171728
- Acronym / sponsor ID
- 1200.4
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Sep 2006 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BIBW 2992dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 (Human Epidermal Growth Factor Receptor), 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBW 2992 | Drug | BIBW 2992 |
Primary outcome
Maximum tolerated dose (MTD) of BIBW 2992
Time frame: up to 168 days
Incidence and intensity of Adverse Events according to Common Terminology Criteria (CTC version 3)
Time frame: up to 23 months
12 secondary outcomes
Area under the plasma concentration-time curve (AUC) for several time points
Time frame: up to 28 days
Predose plasma concentration
Time frame: Predose on day 8, 15, 22 and 27
Plasma concentration at 24 h following the first (C24,1) and the Day 27 dose (C24,27)
Time frame: 24 hours after drug administration on day 24 and 27
Plasma concentration at 3 h following the first dose (C3,1)
Time frame: 3 hours after the first dose on day 1
Maximum measured plasma concentration at steady state on Day 27 (Cmax,ss)
Time frame: up to 24 hours after drug administration on day 27
Time from dosing to the maximum plasma concentration at steady state on Day 27 (tmax,ss)
Time frame: up to 24 hours after drug administration on day 27
Terminal half-life at steady state (t1/2,ss)
Time frame: up to 28 days
Mean residence time after oral administration at steady state (MRTpo,ss)
Time frame: up to 28 days
Apparent clearance at steady state (CL/F,ss)
Time frame: up to 28 days
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Time frame: up to 28 days
Objective tumor responses
Time frame: up to 23 months
Correlation of EGFR (epidermal growth factor receptor), HER2, estrogen receptor (ER) and progesterone receptor (PrR) immunohistochemical status as based on tumor biopsies, or excisions obtained prior to this trial, with objective tumor responses
Time frame: up to 23 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 24 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 168 days). 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?
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.