NCT01436565

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2011

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

2.5 years

First QC Date

September 7, 2011

Last Update Submit

June 12, 2014

Conditions

Solid Tumor Cancers

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    2 months to 12 months

Secondary Outcomes (5)

  • Peak and trough levels of SAR256212 and SAR245408

    1 month to 6 months

  • Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured

    1 month to 6 months

  • Number of participants with adverse events

    1 month to 2 years

  • overall response rate

    2 months to 2 years

  • Number of patients who develop anti-MM-121 antibodies

    1 month to 6 months

Study Arms (1)

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

Drug: MM-121 (SAR256212)Drug: SAR245408

Interventions

MM-121 (SAR256212)DRUG

Pharmaceutical form:solution Route of administration: Intravenous

dose escalation and expansion
SAR245408DRUG

Pharmaceutical form:tablet Route of administration: oral

dose escalation and expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Investigational Site Number 840001

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 840101

Brookline, Massachusetts, 02115, United States

Location

Investigational Site Number 840002

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

seribantumabXL147

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 19, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

US(3)