NeoplasmsPhase 1NCT02171741
Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors
A Phase 1 study testing BIBW 2992 and Docetaxel in people with Neoplasms, run by Boehringer Ingelheim.
Trial summary
Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy. 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 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 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 tumors, of types historically known to express EGFR and/or HER2, who are amenable to docetaxel, preferably patients with breast, prostate, or non-small cell lung cancer. Patients must have failed prior standard therapies associated with clinical benefits, including survival benefits, if such therapies are available. If docetaxel administration is standard therapy associated with clinical benefits, patients are eligible
- 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 must have resolution from prior chemo-, hormone-, immuno-, or radiotherapy related toxicities to CTC Grade <= 1or baseline for individual patient
- Patients must be recovered from previous surgery
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 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 who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast-feeding
- Concurrent treatment with other investigational drugs, or 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 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 before treatment Day 1 of any new course
- Patient 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 Dose Escalation Trial of BIBW 2992 Administration for 20, 13 or 6 Days in Combination With Docetaxel Every 21 Days
Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2992Drug
continuous daily dosing for 20 or 13 days
DocetaxelDrug
single infusion on day 1
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + BIBW 2992 | Experimental | Not described Receives: Drug: BIBW 2992; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and intensity of AdverseEvents according to Common Terminology Criteria (CTCAE version 3)
Measured: up to 32 months
Maximum tolerated dose (MTD) of BIBW 2992
Measured: up to 126 days
Secondary outcomes (14)
Objective tumor response
Measured: up to 32 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 32 months
Area under the plasma concentration-time curve (AUC) for several time points
Measured: up to 48 hours after administration
The percentage of AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)
Measured: up to 48 hours after administration
Predose plasma concentration (Cpre) for several time points
Measured: predose on day 10 and 21
Plasma concentration at 24 hours (C24)
Measured: 24 hours after the first and the last adminstration of study drug
Maximum measured plasma concentration (Cmax) for several time points
Measured: up to 48 hours after administration
Time from dosing to the maximum plasma concentration (tmax) for several time points
Measured: up to 48 hours after administration
Terminal half-life (t1/2) for several time points
Measured: up to 48 hours after administration
Mean residence time (MRT) for several time points
Measured: up to 48 hours after administration
Apparent clearance (CL/F) for several timt points
Measured: up to 48 hours after administration
Apparent volume of distribution during the terminal phase (Vz/F) for several time points
Measured: up to 48 hours after administration
Terminal rate constant in plasma (λz)
Measured: up to 48 hours after administration
Accumulation ratio between day 1 and day 21 with respect to Cmax (Ra1) and AUC (RA2)
Measured: up to day 21
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 startApr 2005
- Primary completionDec 2007
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
- 31 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
- NCT02171741
- Sponsor's protocol ID
- 1200.6
- 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 Dose Escalation Trial of BIBW 2992 Administration for 20, 13 or 6 Days in Combination With Docetaxel Every 21 Days
- ClinicalTrials.gov ID
- NCT02171741
- Acronym / sponsor ID
- 1200.6
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2007 (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.
Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + BIBW 2992 | Experimental | Drug: BIBW 2992, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 are amenable to docetaxel, preferably patients with breast, prostate, or non-small cell lung cancer. Patients must have failed prior standard therapies associated with clinical benefits, including survival benefits, if such therapies are available. If docetaxel administration is standard therapy associated with clinical benefits, patients are eligible
- 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 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 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 |
|---|---|---|
| BIBW 2992continuous daily dosing for 20 or 13 days | Drug | Docetaxel + BIBW 2992 |
| Docetaxelsingle infusion on day 1 | Drug | Docetaxel + BIBW 2992 |
Primary outcome
Incidence and intensity of AdverseEvents according to Common Terminology Criteria (CTCAE version 3)
Time frame: up to 32 months
Maximum tolerated dose (MTD) of BIBW 2992
Time frame: up to 126 days
14 secondary outcomes
Objective tumor response
Time frame: up to 32 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 32 months
Area under the plasma concentration-time curve (AUC) for several time points
Time frame: up to 48 hours after administration
The percentage of AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)
Time frame: up to 48 hours after administration
Predose plasma concentration (Cpre) for several time points
Time frame: predose on day 10 and 21
Plasma concentration at 24 hours (C24)
Time frame: 24 hours after the first and the last adminstration of study drug
Maximum measured plasma concentration (Cmax) for several time points
Time frame: up to 48 hours after administration
Time from dosing to the maximum plasma concentration (tmax) for several time points
Time frame: up to 48 hours after administration
Terminal half-life (t1/2) for several time points
Time frame: up to 48 hours after administration
Mean residence time (MRT) for several time points
Time frame: up to 48 hours after administration
Apparent clearance (CL/F) for several timt points
Time frame: up to 48 hours after administration
Apparent volume of distribution during the terminal phase (Vz/F) for several time points
Time frame: up to 48 hours after administration
Terminal rate constant in plasma (λz)
Time frame: up to 48 hours after administration
Accumulation ratio between day 1 and day 21 with respect to Cmax (Ra1) and AUC (RA2)
Time frame: up to day 21
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.
- Related InfoLink provided by the sponsor.
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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 and Docetaxel 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 7 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?
Incidence and intensity of AdverseEvents according to Common Terminology Criteria (CTCAE version 3) (time frame: up to 32 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?
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.