Advance Solid TumorsPhase 1NCT01213381
Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors
A Phase 1 study testing Iniparib (SAR240550 - BSI-201), Gemcitabine and Carboplatin in people with Advance Solid Tumors, run by Sanofi at 2 sites in Japan.
Trial summary
Primary Objective: To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens Secondary Objectives: To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin To assess safety profiles: significant… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advance Solid Tumors
- What is being tested?
- Iniparib (SAR240550 - BSI-201), Gemcitabine and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2010to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Known hematological 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 New York Heart Association >class II, uncontrolled hypertension
- Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection
- Major surgery within 28 days of study Day 1
Show all 16Show fewer
- Not recovered from all previous therapies (i.e. radiation, surgery, and medications)
- Adverse events related to previous therapies must be Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the subject's baseline prior to their most recent previous therapy
- Inadequate organ and bone marrow function Radiation therapy within 14 days of study Day 1
- Chemotherapy or antibody therapy for treatment of underlying malignancy within 21 days of study Day 1
- Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy
- Currently enrolled or was enrolled within 30 days of completing other investigational drug study, or receiving other investigational agent not approved for any indications
- Subject who had been previously enrolled in this study . Not available for follow-up assessment
- Any kind of disorder that compromised the ability of the subject to give written informed consent and/or comply with the study procedures
- Patient who is judged by the investigator as not suitable for participation in the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Sanofi-Aventis Investigational Site Number 392001
Kobe
Sanofi-Aventis Investigational Site Number 392002
Matsuyama
About this study
Official title: A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.
Primary Objective:
- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens
Read more
Secondary Objectives:
- To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin
- To assess safety profiles: significant laboratory changes and adverse events (AEs)
- To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease
- To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics
- To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)
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.
Read the detailed description
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.
- Conditions
- Advance Solid Tumors
- Being tested
- Iniparib (SAR240550 - BSI-201), Gemcitabine, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iniparib (SAR240550 - BSI-201)Drug
Pharmaceutical form:sterile aqueous solution
Route of administration: intravenous
GemcitabineDrug
Pharmaceutical form:sterile aqueous solution
Route of administration: intravenous
CarboplatinDrug
Pharmaceutical form:sterile aqueous solution
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR240550 | Experimental | * single cohort: SAR240550
* combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin Receives: Drug: Iniparib (SAR240550 - BSI-201); Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity in cycle 1
Measured: 3 Weeks
Secondary outcomes (5)
Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 30 days after the last injection
Safety based on clinical and laboratory tests and Adverse Events (AEs)
Measured: 30 days after the last injection
Pharmacokinetics of SAR240550
Measured: Cycle 1 and Cycle 2
Pharmacodynamics of SAR240550
Measured: Cycle1, Cycle 2 and 30 days after the last injection
Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes
Measured: Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01213381
- Sponsor's protocol ID
- TED11451
- Other IDs
- U1111-1117-3152
- Status last verified
- May 2013
- First submitted
- 30 Sep 2010
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT01213381
- Acronym / sponsor ID
- TED11451
- Conditions
- Advance Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Oct 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.
Primary Objective:
- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens
Secondary Objectives:
- To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin
- To assess safety profiles: significant laboratory changes and adverse events (AEs)
- To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease
- To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics
- To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)
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.
Detailed description
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR240550 | Experimental | Drug: Iniparib (SAR240550 - BSI-201), Drug: Gemcitabine, Drug: Carboplatin* single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available
Key exclusion criteria (16 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Known hematological 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 New York Heart Association >class II, uncontrolled hypertension
- Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection
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 |
|---|---|---|
| Iniparib (SAR240550 - BSI-201)Pharmaceutical form:sterile aqueous solution Route of administration: intravenous | Drug | SAR240550 |
| GemcitabinePharmaceutical form:sterile aqueous solution Route of administration: intravenous | Drug | SAR240550 |
| CarboplatinPharmaceutical form:sterile aqueous solution Route of administration: intravenous | Drug | SAR240550 |
Primary outcome
Dose Limiting Toxicity in cycle 1
Time frame: 3 Weeks
5 secondary outcomes
Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 30 days after the last injection
Safety based on clinical and laboratory tests and Adverse Events (AEs)
Time frame: 30 days after the last injection
Pharmacokinetics of SAR240550
Time frame: Cycle 1 and Cycle 2
Pharmacodynamics of SAR240550
Time frame: Cycle1, Cycle 2 and 30 days after the last injection
Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes
Time frame: Cycle 1
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 May 2013.
Related trials for Advance Solid Tumors
RecruitingObservational study
Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects
Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder
RecruitingPhase 1
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
Solid Tumor
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1/2
Study of JMBI-001 in Patients With MYC-Positive Advanced Cancers
Advance Solid Tumors, Lymphoma, Non-Hodgkin
RecruitingPhase 1
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Advance Solid Tumors
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
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 Iniparib (SAR240550 - BSI-201), Gemcitabine and Carboplatin in people with Advance Solid Tumors, run by Sanofi at 2 sites in Japan.
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 1 inclusion and 16 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 24 May 2013. 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 Japan. 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?
Dose Limiting Toxicity in cycle 1 (time frame: 3 Weeks). 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 May 2013.