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NCT02113878 · ClinicalTrials.gov registry record · Phase 1

Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck

A Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell of Head and Neck, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
1
Study location

NCT02113878: Completed Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell of Head and Neck, sponsored by Dana-Farber Cancer Institute.

NCT02113878 is a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell of Head and Neck that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 23 participants, below the 90-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02113878, a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell of Head and Neck, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

Primary Outcome

The trial uses 3+3 design to determine maximum tolerated dose (MTD).

Interventions

  • DRUG Cisplatin
  • DRUG BKM120
  • RADIATION Intensity-modulated radiotherapy (IMRT)

Study Locations (1)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2014-09-29
Est. Completion 2022-01-01
Phase Phase 1
Dana-Farber Cancer Institute

781 total trials

What the finished NCT02113878 record still lists

NCT02113878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 90-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (74% lower).

The record links to 6 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT02113878 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02113878 about?

NCT02113878 is a clinical study titled "Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck". This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

What is the current status of trial NCT02113878?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2014-09-29. Estimated completion is 2022-01-01.

What conditions does trial NCT02113878 study?

This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Hypopharyngeal Cancer, Early Invasive Cervical Squamous Cell Carcinoma, Carcinoma of Larynx.

What interventions are being tested in trial NCT02113878?

The interventions under investigation include: Cisplatin (DRUG), BKM120 (DRUG), Intensity-modulated radiotherapy (IMRT) (RADIATION).

Who is sponsoring clinical trial NCT02113878?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02113878 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02113878's enrollment target sits among peer trials

23 15th of 16 higher than 2 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02113878, the US trial registry maintained by the National Library of Medicine. NCT02113878 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.