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A Phase 1/2 Study of XL147 (SAR245408) Administered in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer, Breast Neoplasms

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Trial Information

A Phase 1/2 Study of XL147 (SAR245408) Administered in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen

Inclusion Criteria:

- The subject has pathologically and radiologically confirmed metastatic HER2 positive
breast cancer (Stage IV disease). Subjects must have received and progressed on at
least one prior trastuzumab-containing regimen for metastatic disease. For subjects
in Arm 2, they must also have received at least one prior taxane-containing regimen.

- The subject has at least one lesion that is not within a previously radiated field
and measurable on computerized tomography (CT) or magnetic resonance imaging scan

- The subjects enrolled in Phase 2 must be willing to undergo a biopsy of the primary
tumor or a tumor metastasis at baseline, if tumor tissue is amenable to biopsy

- The subject's primary tumor and/or metastatic lesion must overexpress HER2

- For subjects enrolled in Phase 2: samples from archival or fresh tissue, or a tissue
block of the subject's tumor.

- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤

- The subject has adequate organ and marrow function

- The subject is capable of understanding the informed consent and complying with the
protocol and has signed the informed consent document prior to any study-specific
screening procedures or evaluations being performed.

- Sexually active subjects must agree to use a medically-accepted barrier method of
contraception during the course of the study and for 3 months following
discontinuation of study treatments. For subjects using oral contraceptives, a
barrier method must be used in addition to the oral contraceptive

- Subjects of childbearing potential must have a negative pregnancy test at screening
and enrollment

Exclusion Criteria:

- The subject has previously been treated with a selective inhibitor of PI3K and / or

- Certain restrictions on prior therapies apply

- The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to
pre-therapy baseline

- The subject has untreated, symptomatic, or progressive brain metastases. Any
corticosteroid use for brain metastases must have been discontinued without the
subsequent appearance of symptoms for ≥4 weeks prior to first study treatment

- The subject has prothrombin time/International Normalized Ratio (PT/INR) or partial
thromboplastin time (PTT) test results at screening that are ≥ 1.3 times above the
laboratory upper limit of normal

- The subject has a diagnosis of uncontrolled diabetes mellitus

- The subject has uncontrolled significant intercurrent illness

- The subject has uncontrolled hypertension or other clinically significant
cardiovascular disease

- The subject has left ventricular ejection fraction (LVEF) ≤ 50%

- The subject has a baseline corrected QT interval ≥ 460 ms

- The subject is currently receiving anticoagulation with therapeutic doses of warfarin
(low-dose warfarin ≤ 1mg/day is permitted)

- The subject is pregnant or breastfeeding

- The subject is known to be positive for the human immunodeficiency virus (HIV) (a
test for HIV at screening is not required)

- The subject has any other diagnosis of malignancy or evidence of malignancy (except
non-melanoma skin cancer, in situ carcinoma of the cervix) within 2 years prior to
screening for this study

- The subject has a previously identified allergy or hypersensitivity or is intolerant
to components of any of the study treatment formulations

- The subject is unable or unwilling to abide by the study protocol or cooperate fully
with the investigator or designee

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of XL147 in combination with trastuzumab and in combination with trastuzumab and paclitaxel

Outcome Time Frame:

safety assessments at weekly study visits

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • HER2 positive breast cancer
  • breast cancer
  • breast tumors
  • human mammary carcinoma
  • Breast Neoplasms
  • Neoplasms



Investigational Site Number 1214Nashville, Tennessee  37203
Investigational Site NumberLos Angeles, California  90033
Investigational Site Number 1537Los Angeles, California  90033
Investigational Site Number 1238Fort Meyers, Florida  33901
Investigational Site Number 1138Boston, Massachusetts  02115
Investigational Site Number 1330Detroit, Michigan  48201
Investigational Site Number 1151Bronx, New York  10467
Investigational Site Number 1150New York, New York  10032
Investigational Site Number 1246Nashville, Tennessee  37232