TumorsPhase 1NCT00422682
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
A Phase 1 study testing bsi-201 + topotecan, bsi-201 + temozolomide and bsi-201 + gemcitabine in people with Tumors, run by Sanofi at 6 sites in United States.
Trial summary
The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors. 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 + topotecan, bsi-201 + temozolomide and bsi-201 + gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2007to Oct 2012
- 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
- ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
- At least a 14-day period from end of last dose of chemotherapy received
- Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1
Who cannot join
- Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
- Hematological malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
- History of seizure disorder
- Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension
- Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
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- Specified concomitant medications
- Serum creatinine > 1.5 x upper limit of normal (ULN)
- Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases; total bilirubin > 1.5 x ULN
- Radiation therapy within 14 days of study day 1
- Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
- Concurrent radiation therapy is not permitted throughout the course of the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Detroit, Michigan
Research Site
Houston, Texas
Research Site
New Haven, Connecticut
Research Site
New York, New York
Research Site
Philadelphia, Pennsylvania
Research Site
San Antonio, Texas
About this study
Official title: A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors.
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 + topotecan, bsi-201 + temozolomide, bsi-201 + gemcitabine, bsi-201 + carboplatin/paclitaxel
- Keywords
- Solid tumors
- 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 + topotecanDrug
21 day cycle
bsi-201 + temozolomideDrug
28 day cycle
bsi-201 + gemcitabineDrug
28 day cycle
bsi-201 + carboplatin/paclitaxelDrug
21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BSI-201 + topotecan Receives: Drug: bsi-201 + topotecan |
| 2 | Experimental | BSI-201 + temozolomide Receives: Drug: bsi-201 + temozolomide |
| 3 | Experimental | bsi-201 + gemcitabine Receives: Drug: bsi-201 + gemcitabine |
| 4 | Experimental | bsi-201 + carboplatin/paclitaxel Receives: Drug: bsi-201 + carboplatin/paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy
Measured: ongoing
Response rate (CR + PR)
Measured: every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionOct 2012
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422682
- Sponsor's protocol ID
- TCD11484
- Other IDs
- 20060102
- Status last verified
- Jun 2016
- First submitted
- 12 Jan 2007
- Last updated
- 10 Jun 2016
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00422682
- Acronym / sponsor ID
- TCD11484
- Conditions
- Tumors
- Keywords
- Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Jan 2007 (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 the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors.
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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bsi-201 + topotecanBSI-201 + topotecan |
| 2 | Experimental | Drug: bsi-201 + temozolomideBSI-201 + temozolomide |
| 3 | Experimental | Drug: bsi-201 + gemcitabinebsi-201 + gemcitabine |
| 4 | Experimental | Drug: bsi-201 + carboplatin/paclitaxelbsi-201 + carboplatin/paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
- At least a 14-day period from end of last dose of chemotherapy received
- Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1
Key exclusion criteria (12 listed)
- Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
- Hematological malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
- History of seizure disorder
- Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension
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 + topotecan21 day cycle | Drug | 1 |
| bsi-201 + temozolomide28 day cycle | Drug | 2 |
| bsi-201 + gemcitabine28 day cycle | Drug | 3 |
| bsi-201 + carboplatin/paclitaxel21 day cycle | Drug | 4 |
Primary outcome
safety and efficacy
Time frame: ongoing
Response rate (CR + PR)
Time frame: every 2 cycles
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 10 Jun 2016.
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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.
6 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 + topotecan, bsi-201 + temozolomide and bsi-201 + gemcitabine in people with Tumors, run by Sanofi at 6 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 5 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
safety and efficacy (time frame: ongoing). The study lists 2 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 10 Jun 2016.