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A Phase I Study of BKM120, Administered Orally in Adult Chinese Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Breast Cancer, Advanced Carcinomas With Squamous Cell Histology

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Trial Information

A Phase I Study of BKM120, Administered Orally in Adult Chinese Patients With Advanced Solid Tumors

This is a single arm study, with a starting dose of BKM120 at 80mg/day. Two dose levels:
80mg/day and 100mg /day will be tested in the dose escalation phase. At least 3 patients
will be enrolled at each dose level and at least 6 evaluable patients required to be treated
at the recommended Phase II dose(RP2D)/MTD dose. After dose escalation the 80mg/day and the
100mg /day dose levels will be expanded to evaluate up to approximately a total of 15
patients each (if 100mg is determined as the RP2D/MTD).

Inclusion Criteria:

- Patients with histologically-confirmed, advanced unresectable breast cancer or
advanced carcinoma with squamous cell histology (including NSCLC, SCCHN, and
esophageal) who have progressed on (or not been able to tolerate) standard therapy or
for whom no standard anticancer therapy exists

- Patient must provide a representative archival or fresh tumor biopsy for shipping to
a Novartis designated laboratory for profiling. Note: one block or ≥ 15 unstained
slides is required to determine the PI3K activation status. Whenever possible ≥ 20
unstained slides is preferred.

- Patient has measurable and/or non-measurable disease as per RECIST v1.1 guidelines
for solid tumors

- Patient is an adult (female or male) ≥ 18 years of age on the day of consent

- Patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2

Exclusion Criteria:

- Patient has received previous treatment with a PI3K inhibitor

- Patient has symptomatic CNS metastases

- Patients with asymptomatic CNS metastases may participate in this trial. The patient
must have completed any prior local treatment for CNS metastases ≥ 14 days prior to
the start of study treatment (including radiotherapy and/or surgery). If the patient
is receiving ongoing corticosteroid therapy, the following criteria must be met:

- The patient must be receiving a stable or decreasing dose ≤ dexamethasone 4 mg/day or
equivalent anti-inflammatory potency of another corticosteroid

- The dose of corticosteroid may not have been escalated for at least 14 days before
the start of study treatment

- Patient is currently receiving increasing or chronic treatment with corticosteroids
(>dexamethasone 4 mg or equivalent anti-inflammatory potency of another
corticosteroid) or another immunosuppressive agent.

- Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways
diseases), eye drops or local injections (e.g., intra-articular) are allowed.
Patients with previously treated and asymptomatic brain metastases, are permitted to
use corticosteroids as per specific protocol criteria

- Patient is currently receiving treatment with drugs known to be moderate or strong
inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong
inducers for at least one week and must have discontinued strong inhibitors before
the treatment is initiated. Switching to a different medication prior to starting
study treatment is allowed.

- Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

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

Outcome Measure:

Dose Limiting Toxicity (DLT)

Outcome Description:

An adaptive Bayesian logistic regression model (BLRM) for dose escalation with overdose control will guide the dose escalation. The recommended dose is the one with the highest posterior probablity of DLT in the target interval(16%,33%) among the doses fulfilling the overdose criterion that there is less than 25 % chance of excessive toxicity. A clinical synthesis of the available toxicity information including adverse event that are not DLTs, Pharmacokinetics, Pharmacodynamics, efficacy as well as the recommnendations from the BLRM will be used to determine the dose.

Outcome Time Frame:

During Cycle 1 (28 days)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


China: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

March 2014

Related Keywords:

  • Advanced Breast Cancer, Advanced Carcinomas With Squamous Cell Histology
  • Breast cancer, NSCLC, SCCHN, esophageal cancer
  • Breast Neoplasms
  • Carcinoma