NeoplasmsPhase 1NCT02171676
BIBW 2992 After Administration of Docetaxel in Patients With Advanced Solid Tumors
A Phase 1 study testing Docetaxel and BIBW 2992 in people with Neoplasms, run by Boehringer Ingelheim.
Trial summary
Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Docetaxel and BIBW 2992
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Mar 2008
- 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 preferably patients with breast, prostate, or ovarian cancer. In addition, patients with a disease amenable for standard treatment with docetaxel
- 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 or 1
- Patients recovered (Common Terminology Criteria (CTC) Grade 0 or 1) from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies
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- Patients recovered from previous surgery
- The 12 additional patients recruited at the MTD must also meet the following criteria:
- Measurable tumor deposits (Response Evaluation Criteria in Solid Tumors) by one or more techniques (X-ray, CT, MRI) and/or recognized tumor markers such as prostate specific antigen (prostate cancer) or cancer antigen 125 (Ovarian cancer)
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
- 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 weeks, no history of cerebral edema or bleeding in the past eight 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 > upper limit of normal (ULN)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) > 1.5 x ULN
- Alkaline Phosphatase > 2.5 x ULN
- Serum creatinine > 1.5 mg / dl (> 132 μmol / L, SI (Système Internationale) unit equivalent)
- Women and men 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 luteinising hormone-releasing hormone 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
- 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
- Hypersensitivity to docetaxel or any component or other drug formulated with polysorbate 80
- The patient may be eligible for re-treatment after the previous course is finished. The patient will not be eligible if any of the following conditions are met:
- If patients latest X-ray, CT or MRI reveals progressive disease, or if clinical assessment reveals signs of disease progression
- 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 on day 18 of the treatment course 1 (visit 7) or day 18 (visit R5) of the previous course
- Patients not recovered from any dose-limiting toxicity (DLT) 14 days after onset. 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 Single Oral Daily Doses of BIBW 2992 for Three Days After Administration of Docetaxel, in Patients With Advanced Solid Tumors
Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
BIBW 2992Drug
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + BIBW 2992 | Experimental | Dose escalation Receives: Drug: Docetaxel; Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: up to 168 days
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE version 3.0)
Measured: up to 35 months
Secondary outcomes (15)
Area under the plasma concentration-time curve (AUC) for different time points
Measured: up to 48 hours after the first drug administration
Percentage of AUC0-∞ that is obtained by extrapolation (%AUC0-tz)
Measured: up to 48 hours after the first drug administration
Pre-dose plasma concentration (Cpre)
Measured: pre-dose on day 3 and 4
Plasma concentration at 24 h following the first (C24,1) dose
Measured: 24 hours after the first drug administration
Maximum measured plasma concentration (Cmax)
Measured: up to 48 hours after the first drug administration
Time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax)
Measured: up to 48 hours after the first drug administration
Terminal rate constant in plasma (λz )
Measured: up to 48 hours after the first drug administration
Terminal half-life (t1/2)
Measured: up to 48 hours after the first drug administration
Mean residence time after oral administration (MRTpo)
Measured: up to 48 hours after the first drug administration
Apparent clearance (CL/F)
Measured: up to 48 hours after the first drug administration
Apparent volume of distribution (V) for different time points
Measured: up to 48 hours after the first drug administration
Modulation of biomarkers (EGFR (Epidermal growth factor receptor), p-EGFR, p-MAPK (mitogen-activated protein kinase), p-Akt, Ki 67, p27Kip1) in skin biopsies
Measured: Baseline and day 4
Modulation of biomarkers (EGFR, p-EGFR, HER2 (Human epidermal growth factor receptor), p-MAPK, p-Akt, Ki 67, p27Kip1) in tumour biopsies in 6 or more patients treated at the MTD
Measured: Baseline and day 4
Objective tumor response
Measured: up to 35 months
Correlation of EGFR, 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 35 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 startMay 2005
- Primary completionMar 2008
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02171676
- Sponsor's protocol ID
- 1200.20
- 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 Single Oral Daily Doses of BIBW 2992 for Three Days After Administration of Docetaxel, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02171676
- Acronym / sponsor ID
- 1200.20
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Mar 2008 (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.
Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + BIBW 2992 | Experimental | Drug: Docetaxel, 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, 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, prostate, or ovarian cancer. In addition, patients with a disease amenable for standard treatment with docetaxel
- 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 or 1
Key exclusion criteria (23 listed)
- 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
- 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 weeks, no history of cerebral edema or bleeding in the past eight 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 |
|---|---|---|
| DocetaxelAlso: Taxotere | Drug | Docetaxel + BIBW 2992 |
| BIBW 2992 | Drug | Docetaxel + BIBW 2992 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: up to 168 days
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE version 3.0)
Time frame: up to 35 months
15 secondary outcomes
Area under the plasma concentration-time curve (AUC) for different time points
Time frame: up to 48 hours after the first drug administration
Percentage of AUC0-∞ that is obtained by extrapolation (%AUC0-tz)
Time frame: up to 48 hours after the first drug administration
Pre-dose plasma concentration (Cpre)
Time frame: pre-dose on day 3 and 4
Plasma concentration at 24 h following the first (C24,1) dose
Time frame: 24 hours after the first drug administration
Maximum measured plasma concentration (Cmax)
Time frame: up to 48 hours after the first drug administration
Time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax)
Time frame: up to 48 hours after the first drug administration
Terminal rate constant in plasma (λz )
Time frame: up to 48 hours after the first drug administration
Terminal half-life (t1/2)
Time frame: up to 48 hours after the first drug administration
Mean residence time after oral administration (MRTpo)
Time frame: up to 48 hours after the first drug administration
Apparent clearance (CL/F)
Time frame: up to 48 hours after the first drug administration
Apparent volume of distribution (V) for different time points
Time frame: up to 48 hours after the first drug administration
Modulation of biomarkers (EGFR (Epidermal growth factor receptor), p-EGFR, p-MAPK (mitogen-activated protein kinase), p-Akt, Ki 67, p27Kip1) in skin biopsies
Time frame: Baseline and day 4
Modulation of biomarkers (EGFR, p-EGFR, HER2 (Human epidermal growth factor receptor), p-MAPK, p-Akt, Ki 67, p27Kip1) in tumour biopsies in 6 or more patients treated at the MTD
Time frame: Baseline and day 4
Objective tumor response
Time frame: up to 35 months
Correlation of EGFR, 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 35 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 Docetaxel and 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 23 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 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.