Solid TumorsPhase 3NCT01593228
Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
A Phase 3 study testing Iniparib (SAR240550/BSI-201), Carboplatin and Doxorubicin HCL liposome injection in people with Solid Tumors, run by Sanofi at 32 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Iniparib (SAR240550/BSI-201), Carboplatin and Doxorubicin HCL liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 32 sitesin 4 countries
- Study dates
- May 2012to Sep 2016
- Phase
- Phase 3
- 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
- Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen.
- Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician.
- Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
- On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.
Who cannot join
- Patient has not previously participated in any clinical trial of iniparib.
- Patient has evidence of progressive disease while receiving iniparib.
- Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol).
- Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart).
- Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss.
- Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol.
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- Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specified on the parental study protocol are not permitted throughout the course of the study.
- Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.)
- Patient is unable to comply with the requirements of the study.
- Pregnant or breast-feeding women.
- Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.
- 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
32 sites in 4 countries.
32 sites in 4 countries
United States29 sites
Investigational Site Number 840010
Albany, New York, 12206
Investigational Site Number 840063
Augusta, Georgia, 30912
Investigational Site Number 840007
Austin, Texas, 78731
Investigational Site Number 840013
Birmingham, Alabama, 35205
Investigational Site Number 840030
Boston, Massachusetts, 02115
Investigational Site Number 840015
Charlotte, North Carolina
Investigational Site Number 840060
Cincinnati, Ohio
Investigational Site Number 840043
Cleveland, Ohio, 44106
Investigational Site Number 840008
Denver, Colorado, 80218
Investigational Site Number 840001
Detroit, Michigan, 48201
Investigational Site Number 840003
El Paso, Texas, 79915
Investigational Site Number 840012
Indianapolis, Indiana, 46227
Investigational Site Number 840002
Jackson, Mississippi, 39202
Investigational Site Number 840027
Jacksonville, Florida, 32256
Investigational Site Number 840022
Las Vegas, Nevada, 89169
Investigational Site Number 840039
Maywood, Illinois, 60153
Investigational Site Number 840028
Memphis, Tennessee, 38120-2146
Investigational Site Number 840006
Minneapolis, Minnesota, 55407-3799
Investigational Site Number 840005
Norfolk, Virginia, 23502
Investigational Site Number 840021
Pittsburgh, Pennsylvania, 15213
Investigational Site Number 840019
Plano, Texas, 75075
Investigational Site Number 840033
Santa Maria, California, 93454-8903
Investigational Site Number 840025
Sioux City, Iowa, 51105
Investigational Site Number 840059
St Louis, Missouri, 63110
Investigational Site Number 840004
St Louis, Missouri, 63141
Investigational Site Number 840055
Tucker, Georgia, 30084
Investigational Site Number 840046
Vallejo, California, 94589
Investigational Site Number 840009
Vancouver, Washington, 98684
Investigational Site Number 840017
Voorhees Township, New Jersey, 08043
About this study
Official title: International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study
The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.
Read the detailed description
The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.
- Conditions
- Solid Tumors
- Being tested
- Iniparib (SAR240550/BSI-201), Carboplatin, Doxorubicin HCL liposome injection, Gemcitabine, Irinotecan
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:Solution
Route of administration: Intravenous
CarboplatinDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
Doxorubicin HCL liposome injectionDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
GemcitabineDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
IrinotecanDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
PaclitaxelDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
TopotecanDrug
Pharmaceutical form:Solution
Route of administration: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
* Drug: Iniparib monotherapy
* Drug: Iniparib + gemcitabine + carboplatin
* Drug: Iniparib + topotecan
* Drug: Iniparib + irinotecan
* Drug: Iniparib + paclitaxel
* Drug: Iniparib + liposomal doxorubicin + carboplatin Receives: Drug: Iniparib (SAR240550/BSI-201); Drug: Carboplatin; Drug: Doxorubicin HCL liposome injection; Drug: Gemcitabine; Drug: Irinotecan; Drug: Paclitaxel; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
Measured: Up to 30 days after last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT01593228
- Sponsor's protocol ID
- LTS12674
- Other IDs
- 2011-006246-33, U1111-1127-0888
- Status last verified
- Sep 2017
- First submitted
- 30 Apr 2012
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study
- ClinicalTrials.gov ID
- NCT01593228
- Acronym / sponsor ID
- LTS12674
- Conditions
- Solid Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 May 2012 (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 and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.
Detailed description
The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Iniparib (SAR240550/BSI-201), Drug: Carboplatin, Drug: Doxorubicin HCL liposome injection, Drug: Gemcitabine, Drug: Irinotecan, Drug: Paclitaxel, Drug: TopotecanPatients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions: * Drug: Iniparib monotherapy * Drug: Iniparib + gemcitabine + carboplatin * Drug: Iniparib + topotecan * Drug: Iniparib + irinotecan * Drug: Iniparib + paclitaxel * Drug: Iniparib + liposomal doxorubicin + carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen.
- Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician.
- Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
- On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.
Key exclusion criteria (12 listed)
- Patient has not previously participated in any clinical trial of iniparib.
- Patient has evidence of progressive disease while receiving iniparib.
- Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol).
- Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart).
- Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss.
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:Solution Route of administration: Intravenous | Drug | 1 |
| CarboplatinPharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
| Doxorubicin HCL liposome injectionPharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
| GemcitabinePharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
| IrinotecanPharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
| PaclitaxelPharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
| TopotecanPharmaceutical form:Solution Route of administration: Intravenous | Drug | 1 |
Primary outcome
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
Time frame: Up to 30 days after last treatment dose
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 19 Sep 2017.
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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
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iniparib (SAR240550/BSI-201), Carboplatin and Doxorubicin HCL liposome injection in people with Solid Tumors, run by Sanofi at 32 sites in 4 countries.
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 4 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Belgium, Italy, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 (time frame: Up to 30 days after last treatment dose). 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 19 Sep 2017.