TumorsPhase 1NCT00298675
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
A Phase 1 study testing BSI-201 (iniparib) and irinotecan in people with Tumors, run by Sanofi at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- BSI-201 (iniparib) and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
- ECOG performance status of 0, 1, or 2
- Adequate hematological status
- Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
- 18 years of age or older
- Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- For phase 1b portion only: metastatic breast cancer
Who cannot join
- Hematologic malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
- Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA > class II, uncontrolled hypertension
- Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
- Major surgery within 1 month of study day 1
- History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
Show all 14Show fewer
- History of seizure disorder or currently on anti-seizure medication
- Systemic chemotherapy or radiation therapy within 28 days of study day 1
- Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
- Evidence of liver disease shown by elevated enzymes
- Evidence of renal disease shown by serum creatinine > 1.5 x upper limit of normal
- Currently receiving platelet of GCF support for any medical condition
- Concurrent use of herbal medications taken with the intent to treat cancer
- Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Houston, Texas
Research Site
New Haven, Connecticut
Research Site
San Antonio, Texas
About this study
Official title: A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
- Conditions
- Tumors
- Being tested
- BSI-201 (iniparib), irinotecan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSI-201 (iniparib)Drug
Also called SAR240550
BSI-201 administered intravenously (IV), 2x weekly
irinotecanDrug
Irinotecan administered weekly, IV.
| Study group | Role | What they receive |
|---|---|---|
| Iniparib | Experimental | Not described Receives: Drug: BSI-201 (iniparib) |
| Iniparib/irinotecan | Experimental | Not described Receives: Drug: BSI-201 (iniparib); Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: After one cycle
Secondary outcomes (1)
Clinical Response
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 posted3 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT00298675
- Sponsor's protocol ID
- TED11483
- Other IDs
- 20060101
- Status last verified
- Aug 2012
- First submitted
- 1 Mar 2006
- Last updated
- 2 Aug 2012
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00298675
- Acronym / sponsor ID
- TED11483
- Conditions
- Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Mar 2006 (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 purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iniparib | Experimental | Drug: BSI-201 (iniparib) |
| Iniparib/irinotecan | Experimental | Drug: BSI-201 (iniparib), Drug: irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
- ECOG performance status of 0, 1, or 2
- Adequate hematological status
- Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
- 18 years of age or older
Key exclusion criteria (14 listed)
- Hematologic malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
- Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA > class II, uncontrolled hypertension
- Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
- Major surgery within 1 month of study day 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 |
|---|---|---|
| BSI-201 (iniparib)Also: SAR240550BSI-201 administered intravenously (IV), 2x weekly | Drug | Iniparib, Iniparib/irinotecan |
| irinotecanIrinotecan administered weekly, IV. | Drug | Iniparib/irinotecan |
Primary outcome
Maximum tolerated dose
Time frame: After one cycle
1 secondary outcome
Clinical Response
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 2 Aug 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.
Clinical Sciences & Operations study director
Sanofi
3 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 BSI-201 (iniparib) and irinotecan in people with Tumors, run by Sanofi at 3 sites 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?
The sponsor lists 7 inclusion and 14 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 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Maximum tolerated dose (time frame: After one cycle). 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 2 Aug 2012.