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A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer

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Trial Information

A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene


Inclusion Criteria:



- Patients with histologically-confirmed, advanced unresectable solid tumors who have
progressed within three months before screening/baseline visit Only patients who have
confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for
screening (patients participating in the combination arm must be eligible for
treatment with fulvestrant)

- Availability of a representative formalin fixed paraffin embedded tumor tissue sample

- At least one measurable or non-measurable lesion

- Age ≥ 18 years

- World Health Organization (WHO) Performance Status ≤ 2

- Good organ (hepatic, kidney, BM) function at screening/baseline visit

Exclusion Criteria:

- Brain metastasis unless treated and free of signs/symptoms attributable to brain
metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is
allowed).

- Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit

- Patient with peripheral neuropathy NCI-CTC Grade ≥ 3

- Patient with diarrhea NCI-CTC Grade ≥ 2

- Patient with acute or chronic pancreatitis

- Impaired cardiac function or clinically significant cardiac disease incl. unstable
angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial
Infarction (AMI) ≤ 3 months prior to starting study drug.

- Patients with clinically manifest diabetes mellitus, history of gestational diabetes
mellitus or documented steroid-induced diabetes mellitus

- Women who are pregnant or breast feeding or adults of reproductive potential not
employing an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD (or RP2D) of oral BYL719 as single agent and in combination with fulvestrant

Outcome Description:

Incidence rate of dose limiting toxicities (DLT) (in the first cycle (of 28 days) of each investigated dose level).

Outcome Time Frame:

February 2013

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBYL719X2101

NCT ID:

NCT01219699

Start Date:

October 2010

Completion Date:

April 2014

Related Keywords:

  • Advanced Solid Tumors With an Alteration of the PIK3CA Gene
  • Estrogen Receptor Positive Breast Cancer
  • advanced solid tumors
  • mutation
  • amplification
  • wild type
  • PIK3CA gene
  • dose-escalation
  • estrogen receptor positive breast cancer
  • Breast Neoplasms

Name

Location

Vanderbilt Univeristy SCNashville, Tennessee  37232
Massachusetts General Hospital MGHBoston, Massachusetts  02114
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)Nashville, Tennessee  37203
MD Anderson Cancer Center/University of Texas MD AndersonHouston, Texas  77030-4009
University of California San Francisco UCSF Mount ZionSan Francisco, California  94101