A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01387321
First received: June 27, 2011
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

In this study, BYL719 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.


Condition Intervention Phase
Advanced Solid Tumor
Drug: BYL719
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety assessed by type, frequency and severity of adverse events [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.

  • Efficacy assessed by RECIST [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.

    RECIST - Response Evaluation Criteria In Solid Tumors


  • To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.

  • Levels of biomarkers in tumor and skin [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.


Estimated Enrollment: 36
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BYL719 Drug: BYL719

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample
  • At least one measurable or non-measurable lesion Age ≥ 18 years
  • Eastern Cooperative Oncology Group(ECOG) 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 and anti-epileptic therapy.
  • Prior treatment with PI3K inhibitor
  • Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387321

Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

Locations
Japan
Novartis Investigative Site Recruiting
Nagoya, Aichi, Japan, 460-0001
Novartis Investigative Site Recruiting
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site Recruiting
Koto, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01387321     History of Changes
Other Study ID Numbers: CBYL719X1101
Study First Received: June 27, 2011
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Pi3K
Advanced solid tumor

ClinicalTrials.gov processed this record on July 28, 2014