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A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC) Patients Who Are Resistant or Ineligible/Intolerant to Platinum-based Chemotherapy., Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma

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Trial Information

A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Inclusion Criteria:



- Age ≥ 18 years

- Patients with histologically/cytologically-confirmed HNSCC

- Patients must be resistant to platinum-based chemotherapy, or be ineligible (due to
medical comorbidities) or intolerant to platinum-based therapy per medical history

- For Phase Ib, there is no restriction on the number of prior therapies for recurrent
or metastatic disease

- For Phase II, patients may have received a maximum of 1 prior therapy for recurrent
or metastatic disease

- For Phase Ib, prior cetuximab or other EGFR-targeted antibody therapy is allowed
regardless of the prior treatment settings.

- For Phase II, prior cetuximab or other EGFR-targeted antibody therapy is allowed only
if administered in the induction setting, or concurrently with radiation in the
curative setting, with the last dose of cetuximab administered at least 12 months
prior to starting the study treatment

- Patients with swallowing dysfunction that are not using feeding tubes can participate
in the Phase Ib arm B; for the Phase II, these patients may participate if the
administration of drinkable suspension of BYL719 is allowed to be used in Phase II

- Availability of a representative tumor specimen

- At least one measurable or non-measurable lesion as per RECIST 1.1 criteria for
patients in Phase Ib; Measurable disease as determined by RECIST v1.1 for Phase II
patients

- World Health Organization (WHO) Performance Status (PS) ≤ 2

- Adequate organ function

- Negative serum pregnancy test

Exclusion Criteria:

- Prior treatment with PI3K-inhibitors

- Patients with a prior serious infusion reaction to cetuximab

- Patients with uncontrolled CNS tumor metastatic involvement

- Clinically significant cardiac disease or impaired cardiac function

- Patients with diabetes mellitus

- Impaired GI function or GI disease

- History of another malignancy within 2 years prior to starting study treatment

- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (Cycle 1=28 days)

Outcome Description:

Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction)

Outcome Time Frame:

approximately 6 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Therapeutic Goods Administration (TGA)

Study ID:

CBYL719X2104

NCT ID:

NCT01602315

Start Date:

November 2012

Completion Date:

February 2015

Related Keywords:

  • Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC) Patients Who Are Resistant or Ineligible/Intolerant to Platinum-based Chemotherapy.
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • BYL719
  • PI3K inhibitor
  • PIK3CA
  • cetuximab
  • EGFR
  • HNSCC
  • RM HNSCC
  • platinum-based chemotherapy
  • (RM HNSCC) patients
  • resistant or ineligible/intolerant to platinum-based chemotherapy
  • swallowing dysfunction
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Massachusetts General Hospital Mass General 2Boston, Massachusetts  02114
University of Chicago Medical Center University of Chicago (16)Chicago, Illinois  60546
University of California San Francisco UCSF 3San Francisco, California  94101
Emory University School of Medicine/Winship Cancer Institute Dept of OncologyAtlanta, Georgia  30322
Mount Sinai School of Medicine SCNew York, New York  10029
Memorial Sloan Kettering Cancer Center MSKCC NYNew York, New York  10021
Vanderbilt University Medical Center Vanderbilt 2Nashville, Tennessee  37232
MD Anderson Cancer Center/University of Texas Univ TX MD Anderson 2Houston, Texas  77030-4009