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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02298595
Other study ID # 14-057
Secondary ID CBYL719XUS08T
Status Withdrawn
Phase Phase 1/Phase 2
First received November 11, 2014
Last updated November 8, 2017
Start date August 2016
Est. completion date August 2024

Study information

Verified date November 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the combination of BYL719, cisplatin and cetuximab as induction chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy (IMRT) in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).


Description:

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Study Design


Intervention

Drug:
cisplatin
75 mg/m2 IV day 1 of each cycle
Cetuximab
XXXX day 1, 8, and 15 of each cycle
BYL719
200, 250, 300, or 350 mg/day by mouth every day

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Julie E. Bauman, MD, MPH Novartis

Outcome

Type Measure Description Time frame Safety issue
Primary Complete clinico-radiologic response of primary tumor following induction therapy 10-11 weeks
Secondary Pathologic response of primary tumor and lymph nodes following induction therapy 16-19 weeks
Secondary 2 year recurrence-free survival 2 years
Secondary Duration of survival 5 years
Secondary Proportion of patients with genomic PI3K pathway activation who have a complete clinico-radiologic and/or pathologic response to induction therapy Genomic activation defined as: PIK3CA mutation, PIK3CA amplification, and/or PTEN deletion in baseline tumor 10-13 weeks
Secondary Number of participants with adverse events 10-13 weeks
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