Solid Tumor CancersPhase 1NCT01436565
A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers
A Phase 1 study testing MM-121 (SAR256212) and SAR245408 in people with Solid Tumor Cancers, run by Sanofi at 3 sites in United States.
Trial summary
Primary Objective: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancers
- What is being tested?
- MM-121 (SAR256212) and SAR245408
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to May 2014
- 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
- Metastatic or locally advanced nonhematological cancer, for which no alternative therapy is available
- Written informed consent
- For dose expansion only:
- Patient's tumor harbors activating mutations in phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA)
- Tissue from archived sample
- Measurable and evaluable disease
Who cannot join
- Patient less than 18 years old
- ECOG (Eastern Cooperative Oncology Group) performance status >2
- Any serious active disease or comorbid condition, which, in the opinion of the Investigator, could interfere with the safety of the patient or the ability of the patient to comply with the study, or with the interpretation of the results
- Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 109/L or platelets <100 x 109/L
- Poor organ function as defined by 1 of the following:
- Total bilirubin >1.5 x ULN (upper limit of normal)
Show all 26Show fewer
- AST (aspartate aminotransferase) and/or ALT (alanine aminotransferase) >2.5 x ULN
- Serum creatinine >1.5 x ULN and/or creatinine clearance <60 mL/min
- PT/ (INR) (prothrombin time) (International Normalized Ratio) and/or partial thromboplastin time (PTT) test results ≥1.3 ULN
- Pregnant or breast-feeding women
- No use of effective birth control methods, when applicable
- No resolution of all specific toxicities (excluding alopecia) related to any prior anticancer therapy to Grade ≤1 according to the NCI common terminology criteria for adverse events (CTCAE) v.4.0
- Any of the following within 6 months prior to enrollment: myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (Grade 3/4)
- Baseline corrected QT interval (QTc) >460 ms.
- NYHA Class III (New York Heart Association) or IV congestive heart failure or LVEF (left ventricular ejection fraction) < the lower limit of normal (LLN) for institution
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including cytomegalovirus, Epstein-Barr virus, toxoplasmosis, and hepatitis B and C, positive for the human immunodeficiency virus (HIV), hypertension, or uncontrolled diabetes.
- Previous treatment with a selective PI3K inhibitor (phosphoinositide-3-kinase, catalytic, alpha polypeptide), mTOR (mechanistic target of rapamycin) inhibitor, or AKT inhibitor (v-akt murine thymoma viral oncogene homolog 1)
- Known hypersensitivity to the investigational medicinal product(s) or to its excipients, or patient who has had hypersensitivity reactions to fully human monoclonal antibodies
- Cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study treatment
- Prior radiation therapy within 2 weeks before the first dose of study treatment
- Prior major surgery from which the patient has not recovered or stabilized
- Any other investigational therapy within 4 weeks prior to the first dose of study treatment
- Brain tumor or brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks
- Ongoing anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤1 mg/day is permitted).
- HBA1C (hemoglobin A1c) >7 or any patient requiring medication for glycemic control
- 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
3 sites in 1 country.
United States3 sites
Investigational Site Number 840001
Boston, Massachusetts, 02115
Investigational Site Number 840101
Brookline, Massachusetts, 02115
Investigational Site Number 840002
Nashville, Tennessee, 37232
About this study
Official title: A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers
Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.
Secondary Objectives:
- To characterize the global safety profile of SAR245408 in combination with SAR256212
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
- To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
- To determine the immunogenicity of SAR256212 as administered with SAR245408
Read the detailed description
There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
- Conditions
- Solid Tumor Cancers
- Being tested
- MM-121 (SAR256212), SAR245408
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-121 (SAR256212)Drug
Pharmaceutical form:solution
Route of administration: Intravenous
SAR245408Drug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| dose escalation and expansion | Experimental | SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose Receives: Drug: MM-121 (SAR256212); Drug: SAR245408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 2 months to 12 months
Secondary outcomes (5)
Peak and trough levels of SAR256212 and SAR245408
Measured: 1 month to 6 months
Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured
Measured: 1 month to 6 months
Number of participants with adverse events
Measured: 1 month to 2 years
overall response rate
Measured: 2 months to 2 years
Number of patients who develop anti-MM-121 antibodies
Measured: 1 month to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancersStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merrimack Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436565
- Sponsor's protocol ID
- TCD11721
- Other IDs
- U1111-1121-4146
- Status last verified
- Jun 2014
- First submitted
- 7 Sep 2011
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers
- ClinicalTrials.gov ID
- NCT01436565
- Acronym / sponsor ID
- TCD11721
- Conditions
- Solid Tumor Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Merrimack Pharmaceuticals
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Sep 2011 (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 the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.
Secondary Objectives:
- To characterize the global safety profile of SAR245408 in combination with SAR256212
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
- To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
- To determine the immunogenicity of SAR256212 as administered with SAR245408
Detailed description
There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation and expansion | Experimental | Drug: MM-121 (SAR256212), Drug: SAR245408SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metastatic or locally advanced nonhematological cancer, for which no alternative therapy is available
- Written informed consent
- For dose expansion only:
- Measurable and evaluable disease
Key exclusion criteria (26 listed)
- Patient less than 18 years old
- ECOG (Eastern Cooperative Oncology Group) performance status >2
- Any serious active disease or comorbid condition, which, in the opinion of the Investigator, could interfere with the safety of the patient or the ability of the patient to comply with the study, or with the interpretation of the results
- Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 109/L or platelets <100 x 109/L
- Poor organ function as defined by 1 of the following:
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 |
|---|---|---|
| MM-121 (SAR256212)Pharmaceutical form:solution Route of administration: Intravenous | Drug | dose escalation and expansion |
| SAR245408Pharmaceutical form:tablet Route of administration: oral | Drug | dose escalation and expansion |
Primary outcome
Maximum tolerated dose
Time frame: 2 months to 12 months
5 secondary outcomes
Peak and trough levels of SAR256212 and SAR245408
Time frame: 1 month to 6 months
Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured
Time frame: 1 month to 6 months
Number of participants with adverse events
Time frame: 1 month to 2 years
overall response rate
Time frame: 2 months to 2 years
Number of patients who develop anti-MM-121 antibodies
Time frame: 1 month to 6 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 13 Jun 2014.
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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 MM-121 (SAR256212) and SAR245408 in people with Solid Tumor Cancers, 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 6 inclusion and 26 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 13 Jun 2014. 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: 2 months to 12 months). 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 13 Jun 2014.