Multiple MyelomaPhase 1NCT02182141
An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing BIBF 1120 ES in people with Multiple Myeloma, run by Boehringer Ingelheim.
Trial summary
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BIBF 1120 ES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Mar 2005
- 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
- Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
- Age 18 years or older
- Life expectancy of at least six months
- Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
- Eastern Cooperative Oncology Group (ECOG) performance score <2.
- Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.
Who cannot join
- History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
- Active infectious disease
- Uncontrolled, severe hypertension
- Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Absolute neutrophil count less than 1000 / mm³.
Show all 15Show fewer
- Platelet count less than 30 000 / mm³
- Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
- Endogenous creatinine clearance (ECC) <20 ml/min
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breastfeeding
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
About this study
Official title: An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Relapsed or Refractory Multiple Myeloma With Repeated Administration in Patients With Clinical Benefit
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
- Conditions
- Multiple Myeloma
- Being tested
- BIBF 1120 ES
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 ESDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 | Experimental | Not described Receives: Drug: BIBF 1120 ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Up to 11 months
Secondary outcomes (20)
Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120
Measured: Up to 11 months
Change from baseline in laboratory parameters
Measured: Baseline, up to 11 months
Objective tumor response in surrogate markers
Measured: Baseline, up to 11 month
Concentration at 2h (C2,1)
Measured: 2 hours after first administration
Change from baseline in cellular protein tyrosine kinase inhibition
Measured: Baseline, up to 11 months
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score
Measured: Baseline, up to 11 months
Change in vital signs
Measured: up to 11 months
Change from baseline in electrocardiogram (ECG)
Measured: Baseline, up to 11 months
Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)
Measured: Up to day 28
Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)
Measured: Up to 11 months
Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)
Measured: Up to 11 months
Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)
Measured: Up to 11 months
Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)
Measured: Up to 11 months
Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)
Measured: Up to 11 months
Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)
Measured: Up to 11 months
Terminal half-life at steady state (t1/2,ss)
Measured: Up to 11 months
Apparent plasma clearance at steady state (CL/F,ss)
Measured: Up to 11 months
Mean residence time at steady state (MRTpo,ss)
Measured: Up to 11 months
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Measured: Up to 11 months
Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria
Measured: Up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2003
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 17 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
- NCT02182141
- Sponsor's protocol ID
- 1199.2
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Relapsed or Refractory Multiple Myeloma With Repeated Administration in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT02182141
- Acronym / sponsor ID
- 1199.2
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Mar 2005 (actual)
- First posted
- 8 Jul 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, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 | Experimental | Drug: BIBF 1120 ES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
- Age 18 years or older
- Life expectancy of at least six months
- Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
- Eastern Cooperative Oncology Group (ECOG) performance score <2.
Key exclusion criteria (15 listed)
- History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
- Active infectious disease
- Uncontrolled, severe hypertension
- Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
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 |
|---|---|---|
| BIBF 1120 ES | Drug | BIBF 1120 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 11 months
20 secondary outcomes
Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120
Time frame: Up to 11 months
Change from baseline in laboratory parameters
Time frame: Baseline, up to 11 months
Objective tumor response in surrogate markers
Time frame: Baseline, up to 11 month
Concentration at 2h (C2,1)
Time frame: 2 hours after first administration
Change from baseline in cellular protein tyrosine kinase inhibition
Time frame: Baseline, up to 11 months
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score
Time frame: Baseline, up to 11 months
Change in vital signs
Time frame: up to 11 months
Change from baseline in electrocardiogram (ECG)
Time frame: Baseline, up to 11 months
Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)
Time frame: Up to day 28
Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)
Time frame: Up to 11 months
Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)
Time frame: Up to 11 months
Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)
Time frame: Up to 11 months
Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)
Time frame: Up to 11 months
Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)
Time frame: Up to 11 months
Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)
Time frame: Up to 11 months
Terminal half-life at steady state (t1/2,ss)
Time frame: Up to 11 months
Apparent plasma clearance at steady state (CL/F,ss)
Time frame: Up to 11 months
Mean residence time at steady state (MRTpo,ss)
Time frame: Up to 11 months
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Time frame: Up to 11 months
Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria
Time frame: Up to 11 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 18 Jul 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 BIBF 1120 ES in people with Multiple Myeloma, 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 15 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 18 Jul 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 11 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 18 Jul 2014.