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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

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ClinicalTrials.gov Identifier: NCT01387321
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: BYL719 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
Actual Study Start Date : September 22, 2011
Actual Primary Completion Date : November 25, 2015
Actual Study Completion Date : November 25, 2015

Arm Intervention/treatment
Experimental: BYL719 Drug: BYL719



Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 4 Weeks ]

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

  2. Efficacy assessed by RECIST [ Time Frame: 4 months ]

    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


  3. To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2) [ Time Frame: 4 months ]
    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.

  4. Levels of biomarkers in tumor and skin [ Time Frame: 4 months ]
    Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387321


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01387321     History of Changes
Other Study ID Numbers: CBYL719X1101
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pi3K
Advanced solid tumor