NeoplasmsPhase 1NCT00969761
BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
A Phase 1 study testing BI-6727 and BI 6727 in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in Belgium.
Trial summary
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BI-6727 and BI 6727
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesBelgium
- Study dates
- Aug 2009to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Indication for a treatment with platinum therapy as judged by the investigator
- Age 18 years or older
- Written informed consent consistent with ICH-GCP and local legislation
- ECOG performance score lower or equal 2
- Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)
Who cannot join
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Pregnancy or breastfeeding
- Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
- Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
- Second malignancy currently requiring another anti-cancer therapy
- ANC less than 1500 / mm3
Show all 17Show fewer
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 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 micromol / L, SI unit equivalent) or creatinine clearance <70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
- Known history of relevant QT-prolongation, e.g. long QT-syndrome
- Pre-existing clinically relevant hearing loss
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial
- Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
1230.6.3201 Boehringer Ingelheim Investigational Site
Brussels
1230.6.3202 Boehringer Ingelheim Investigational Site
Leuven
About this study
Official title: A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).
Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.
- Conditions
- Neoplasms
- Being tested
- BI-6727, BI 6727
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-6727Drug
Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added
BI 6727Drug
low to high dose
| Study group | Role | What they receive |
|---|---|---|
| A. BI 6727-cisplatin | Experimental | patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin Receives: Drug: BI 6727 |
| B. BI 6727-carboplatin | Experimental | patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin Receives: Drug: BI-6727 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.
0=not maximum tolerated dose, 1=was maximum tolerated dose.
Measured: 3 weeks
Secondary outcomes (23)
Percentage of Participants With Dose Limiting Toxicities
Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.
Measured: 3 weeks
Objective Response Rate
Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).
Tumour response was documented using appropriate techniques
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Objective Response
Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.
Tumour response was documented using appropriate techniques
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best Overall Response
Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Disease Control Rate
Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease Control
Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free Survival
Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Serious Adverse Events
Percentage of participants with serious adverse events (AEs)
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Significant Adverse Events
Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.
DLTs (i.e. significant AEs) per protocol were:
- drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)
- drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection
- drug related CTCAE Grade 4 thrombocytopenia
- drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C)
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Total Plasma Clearance After Intravascular Administration (CL)
Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
Measured: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
Measured: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Change From Baseline in Pulse Rate
Change from baseline in pulse rate at last value on treatment
Measured: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Neutrophils
Change from baseline in neutrophils with the maximum value on treatment
Measured: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Platelets
Change from baseline in platelets with the maximum value on treatment
Measured: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils >=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets >=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.
The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.
Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.
Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Platelets
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Neutrophils
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
Measured: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969761
- Sponsor's protocol ID
- 1230.6
- Other IDs
- 2008-003926-40, 2008
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2009
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Awada A, Dumez H, Aftimos PG, Costermans J, Bartholomeus S, Forceville K, Berghmans T, Meeus MA, Cescutti J, Munzert G, Pilz K, Liu D, Schoffski P. Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. Invest New Drugs. 2015 Jun;33(3):611-20. doi: 10.1007/s10637-015-0223-9. Epub 2015 Mar 22.
PubMed 25794535
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00969761
- Acronym / sponsor ID
- 1230.6
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Posted 31 Jan 2019
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 of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).
Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. BI 6727-cisplatin | Experimental | Drug: BI 6727patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin |
| B. BI 6727-carboplatin | Experimental | Drug: BI-6727patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin |
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 advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Indication for a treatment with platinum therapy as judged by the investigator
- Age 18 years or older
- Written informed consent consistent with ICH-GCP and local legislation
- ECOG performance score lower or equal 2
Key exclusion criteria (17 listed)
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Pregnancy or breastfeeding
- Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
- Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
- Second malignancy currently requiring another anti-cancer therapy
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 |
|---|---|---|
| BI-6727Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added | Drug | B. BI 6727-carboplatin |
| BI 6727low to high dose | Drug | A. BI 6727-cisplatin |
Primary outcome
Maximum Tolerated Dose
Time frame: 3 weeks
The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose.
23 secondary outcomes
Percentage of Participants With Dose Limiting Toxicities
Time frame: 3 weeks
Objective Response Rate
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Objective Response
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best Overall Response
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Disease Control Rate
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease Control
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free Survival
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Serious Adverse Events
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Significant Adverse Events
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Total Plasma Clearance After Intravascular Administration (CL)
Time frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
Time frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Change From Baseline in Pulse Rate
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Neutrophils
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Platelets
Time frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Platelets
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Neutrophils
Time frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25794535Awada A, Dumez H, Aftimos PG, Costermans J, Bartholomeus S, Forceville K, Berghmans T, Meeus MA, Cescutti J, Munzert G, Pilz K, Liu D, Schoffski P. Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. Invest New Drugs. 2015 Jun;33(3):611-20. doi: 10.1007/s10637-015-0223-9. Epub 2015 Mar 22.
- Related InfoLink provided by the sponsor.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI-6727 and BI 6727 in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in Belgium.
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 17 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969761, which also lists 1 linked publication.
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 31 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.