Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
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|ClinicalTrials.gov Identifier: NCT02113878|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell of Head and Neck HPV Positive Oropharyngeal Squamous Cell Carcinoma Hypopharyngeal Cancer Early Invasive Cervical Squamous Cell Carcinoma Carcinoma of Larynx Cancer of Nasopharynx||Drug: BKM120 Drug: Cisplatin Radiation: Intensity-modulated radiotherapy (IMRT)||Phase 1|
- This phase Ib study is combining standard chemoradiotherapy with weekly cisplatin and BKM120 to assess tolerability of this combination in high risk patients with locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN). The investigators will also obtain preliminary information about the efficacy of this treatment.
- The participant will receive the study drug buparlisib once daily, by mouth, for 45 days. The participant will be given a study drug-dosing diary for each cycle. It will include special instructions for taking the study drug at home.
- The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
- All participants will receive weekly cisplatin injection. Cisplatin will be given intra-venously (IV) on days: (1, 8, 15, 22, 29, 36 and 43) at DFCI.
- All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks, delivered at DFCI. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor.
- The investigators would like to keep track of the participant's medical condition. Follow-up will continue every 4 to 12 weeks after the end of treatment for the first year and at the investigator's discretion thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of BKM120 With Weekly Cisplatin and Radiotherapy in High Risk Locally Advanced Squamous Cell Cancer of the Head and Neck|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2020|
BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Other Name: Buparlisib
Cisplatin is a chemotherapy drug
Radiation: Intensity-modulated radiotherapy (IMRT)
IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
Other Name: IMRT
- Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin combination with radiation therapy [ Time Frame: 2 Years ]Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin in combination with radiation therapy in patients with locally advanced squamous cell cancer of the head and neck.
- Overall Response Rate [ Time Frame: 2 Years ]
- Time to Progression [ Time Frame: 2 Years ]
- Survival [ Time Frame: 2 years ]
- Mood alteration from BKM120 [ Time Frame: 2 Years ]
- Activity of BKM120 as single agent in sequential biopsies [ Time Frame: 2 Years ]
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): NCT02113878
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jochen H. Lorch, MD||Brigham and Women's Hospital|