MalignancyPhase 1NCT00863850
Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy
A Phase 1 study testing bendamustine in people with Malignancy, run by Cephalon at 1 site in Netherlands.
Trial summary
An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- bendamustine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to Mar 2010
- 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
- The patient must have a histologically or cytologically confirmed, relapsed or refractory malignancy, except for uveal melanoma, sarcoma or primary brain tumors. Additionally, the malignancy must be considered unresponsive or poorly responsive to accepted treatment modalities.
- The patient has a World Health Organization (WHO) performance status of 0-2.
- The patient has an estimated life expectancy of at least 3 months.
- The patient, if a woman, is surgically sterile, 2 years postmenopausal, or, if of child bearing potential, using a medically accepted method of contraception, and agrees to continued use of this method for the duration of the study and for 90 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (IUD) known to have a failure rate of less than 1% per year.
- The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the study (and for 90 days after taking the last dose of study medication).
- Absolute neutrophil count (ANC) ≥1000 cells/mm3, platelet count ≥100000 cells/mm3, and hemoglobin greater than or equal to 9 g/dL.
- The patient has adequate hepatic function. For patients without liver metastases, adequate hepatic function is defined as ≤2.5 x upper limit of the normal range [ULN] for aspartate aminotransferase [AST] and alanine aminotransferase [ALT], and ≤1.5 x ULN for total bilirubin. For patients with liver metastases, adequate hepatic function is defined as ≤5 x ULN for AST and ALT, and ≤1.5 x ULN for total bilirubin. Patients with non-clinically significant elevations of bilirubin due to known or suspected Gilbert's disease are eligible; this must be documented on the medical history page of the case report form (CRF).
- The patient has a calculated creatinine clearance of >30 mL/minute as determined by the Cockcroft-Gault equation.
Who cannot join
- The patient has had chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days prior to the first dose of study drug or has not recovered from adverse events due to any agents administered previously. For patients who received therapy with mitomycin C, the interval is 42 days.
- The patient has known cerebral metastases.
- The patient is receiving treatment other than bendamustine for hematologic/nonhematologic malignancy.
- The patient has had any previous treatment with bendamustine.
- The patient has been treated with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed).
- The patient is pregnant or lactating.
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- The patient has had a serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, should preclude the patient from participating in the study.
- The patient has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.
- The patient has presence of inflammatory bowel disease, occlusion of the gastrointestinal tract, significant constipation, or any condition resulting in clinically significant obstruction of the urinary tract.
- The patient requires treatment with cytochrome P450 1A2 (CYP1A2) inducers or inhibitors on days 1 through 8 of cycle 1, has used CYP1A2 inhibitors within 14 days before the 1st administration of study drug, or has used CYP1A2 inducers within 30 days before the 1st administration of study drug.
- The patient is a smoker or an ex-smoker who stopped smoking less than 3 months before the 1st dose of study drug or is using or has used topical or oral nicotine preparations for smoking cessation within the past 3 months before the 1st dose of study drug.
- The patient has known hypersensitivity to bendamustine or any if its components (i.e., mannitol).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride Following Intravenous Infusion of [14C] Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy
An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)
- Conditions
- Malignancy
- Being tested
- bendamustine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustineDrug
Bendamustine 120 mg/m2 on Days 1 and 2 every 28 days (one cycle) for up to 6 cycles. Radiolabeled [14C] bendamustine will be given on day 1 of cycle 1 only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative determination of the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy.
Measured: 168 hours (7 days)
Secondary outcomes (1)
Safety and tolerability of bendamustine will be assessed throughout the study.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert - Sr. Director, Clinical Pharmacology, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863850
- Sponsor's protocol ID
- C18083/1039/PK/NL
- Status last verified
- Apr 2012
- First submitted
- 17 Mar 2009
- Last updated
- 23 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride Following Intravenous Infusion of [14C] Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy
- ClinicalTrials.gov ID
- NCT00863850
- Acronym / sponsor ID
- C18083/1039/PK/NL
- Conditions
- Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Mar 2009 (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.
An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must have a histologically or cytologically confirmed, relapsed or refractory malignancy, except for uveal melanoma, sarcoma or primary brain tumors. Additionally, the malignancy must be considered unresponsive or poorly responsive to accepted treatment modalities.
- The patient has a World Health Organization (WHO) performance status of 0-2.
- The patient has an estimated life expectancy of at least 3 months.
- The patient, if a woman, is surgically sterile, 2 years postmenopausal, or, if of child bearing potential, using a medically accepted method of contraception, and agrees to continued use of this method for the duration of the study and for 90 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (IUD) known to have a failure rate of less than 1% per year.
- The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the study (and for 90 days after taking the last dose of study medication).
Key exclusion criteria (12 listed)
- The patient has had chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days prior to the first dose of study drug or has not recovered from adverse events due to any agents administered previously. For patients who received therapy with mitomycin C, the interval is 42 days.
- The patient has known cerebral metastases.
- The patient is receiving treatment other than bendamustine for hematologic/nonhematologic malignancy.
- The patient has had any previous treatment with bendamustine.
- The patient has been treated with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed).
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 |
|---|---|---|
| bendamustineBendamustine 120 mg/m2 on Days 1 and 2 every 28 days (one cycle) for up to 6 cycles. Radiolabeled [14C] bendamustine will be given on day 1 of cycle 1 only. | Drug | 1 |
Primary outcome
Quantitative determination of the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy.
Time frame: 168 hours (7 days)
1 secondary outcome
Safety and tolerability of bendamustine will be assessed throughout the study.
Time frame: 8 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 Apr 2012.
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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.
Sponsor's Medical Expert - Sr. Director, Clinical Pharmacology study director
Cephalon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bendamustine in people with Malignancy, run by Cephalon at 1 site in Netherlands.
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 8 inclusion and 12 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
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?
Quantitative determination of the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy. (time frame: 168 hours (7 days)). 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 Apr 2012.