NeoplasmsPhase 1NCT02171650
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
The primary objective was to collect safety data for 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
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2004to 1 May 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 who have completed the prescribed courses of the 1200.1 or 1200.2 studies without clinical disease progression
- 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 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 (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
Show all 21Show fewer
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, Systeme International (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 birth control
- 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 a clinical study other than 1200.1 or 1200.2
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
- Patients not recovered from any dose-limiting toxicity
- The patients are eligible for re-treatment after the previous course is finished. Patients will not be eligible if the following conditions are met:
- Patients with clinical signs of disease progression or if latest X-ray, CT, MRI or US 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 in Section 3.3 on Day 29 of the previous course
- Patient not recovered from any dose-limiting toxicity (DLT) 14 days after the last administration of BIBW2992 in the previous course. Recovery is defined as return to baseline condition (Visit 1 of 1200.1 or Visit 1 of 1200.2) or CTC Grade 1, whichever is higher.
About this study
Official title: A Phase I Open-label Extension Study of 1200.1 and 1200.2 of Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors
The primary objective was to collect safety data for 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 | Not described Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events, according to Common Terminology Criteria (CTC) version 3, with particular scrutiny of events that were considered to be dose-limiting toxicities and those that were serious or significant
Measured: up to 18 months
Secondary outcomes (1)
Durability of non-progression as measured by tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: every 8 weeks up to 18 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 start1 Dec 2004
- Primary completion1 May 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
- 7 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
- NCT02171650
- Sponsor's protocol ID
- 1200.17
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2014
- Last updated
- 23 Jan 2025
- Results posted
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Extension Study of 1200.1 and 1200.2 of Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02171650
- Acronym / sponsor ID
- 1200.17
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2004 (actual)
- Primary completion
- 1 May 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.
The primary objective was to collect safety data for 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 2992 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients who have completed the prescribed courses of the 1200.1 or 1200.2 studies without clinical disease progression
- 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 (21 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
Incidence and severity of Adverse Events, according to Common Terminology Criteria (CTC) version 3, with particular scrutiny of events that were considered to be dose-limiting toxicities and those that were serious or significant
Time frame: up to 18 months
1 secondary outcome
Durability of non-progression as measured by tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 8 weeks up to 18 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 23 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Related trials for Neoplasms
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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 6 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 23 Jan 2025. 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 severity of Adverse Events, according to Common Terminology Criteria (CTC) version 3, with particular scrutiny of events that were considered to be dose-limiting toxicities and those that were serious or significant (time frame: up to 18 months). 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 23 Jan 2025.