Advanced Solid TumorsPhase 1NCT01161836
An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
A Phase 1 study testing Iniparib in people with Advanced Solid Tumors, run by Sanofi at 1 site in United States.
Trial summary
This is a Phase 1, multi-center, open-label study. During Segment 1, patients are administered a single IV administration of [14C]-iniparib. During Segment 2, patients are administered iniparib with or without additional chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Iniparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old.
Additional criteria are also required and should be evaluated by the research staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Medical Specialties
Tacoma, Washington, 98405
About this study
Official title: An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy
This is a Phase 1, multi-center, open-label study.
During Segment 1, patients are administered a single IV administration of [14C]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
- Conditions
- Advanced Solid Tumors
- Being tested
- Iniparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IniparibDrug
Also called SAR240550, BSI-201
Solution for infusion
60-minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| iniparib | Experimental | Segment 1: 400 mg [14C]-iniparib single administration
Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy Receives: Drug: Iniparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
Measured: Up to 35 days
The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity
Measured: up to 35 days
The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration
Measured: 96 hours
The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.
Measured: Up to 35 days
Secondary outcomes (1)
The clinical and biological tolerability of iniparib.
Measured: During treatment and until 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161836
- Sponsor's protocol ID
- BEX11505
- Other IDs
- 20100109
- Status last verified
- Sep 2013
- First submitted
- 12 Jul 2010
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy
- ClinicalTrials.gov ID
- NCT01161836
- Acronym / sponsor ID
- BEX11505
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Jul 2010 (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.
This is a Phase 1, multi-center, open-label study.
During Segment 1, patients are administered a single IV administration of [14C]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iniparib | Experimental | Drug: IniparibSegment 1: 400 mg [14C]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IniparibAlso: SAR240550, BSI-201Solution for infusion 60-minute intravenous infusion | Drug | iniparib |
Primary outcome
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
Time frame: Up to 35 days
The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity
Time frame: up to 35 days
The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration
Time frame: 96 hours
The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.
Time frame: Up to 35 days
1 secondary outcome
The clinical and biological tolerability of iniparib.
Time frame: During treatment and until 30 days post treatment
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 Sep 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
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 Iniparib in people with Advanced Solid Tumors, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Sep 2013. 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 United States. 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?
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib (time frame: Up to 35 days). The study lists 4 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 Sep 2013.