TriangleNCT02113878 · STUDY IN CONTEXT
Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
The best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria: Complete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is \<10 mm and no new lesions Partial Response (PR) * Disappearance of target lesions and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions or * \>=30% decrease in sum of target lesion diameter and no new lesions Stable Disease (SD) \- Less than 5 mm increase in target lesion diameter unless it results in a \>=20% increase in diameter and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions Progressive Disease (PD) * \>20% increase in target lesion diameter, must be an absolute increase of 5mm or * Substantial worsening in non-target lesion or * New lesion present
The median amount of time from baseline to progression and/or death. Patients known to be alive at last contact are censored at last contact. All patients alive at 24 months from baseline are censored at 24 months.
The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
The median change in score on the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire from baseline to cycle 9.GAD-7 has 7 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 21. Higher score represents worse anxiety.
The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- trial label
- Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
- applicability
- unclear
- applicability note
- Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0000
- source section id
- NCT02113878-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose of Cisplatin
- endpoint definition
- The trial uses 3+3 design to determine maximum tolerated dose (MTD).
- time origin
- While on treatment, up to 66 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- \*One additional patient enrolled in Dose Level 1 per physician discretion
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0001
- source section id
- NCT02113878-om-0001
- source outcome index
- 1
- endpoint
- Best Overall Response
- endpoint definition
- The best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria: Complete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is \<10 mm and no new lesions Partial Response (PR) * Disappearance of target lesions and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions or * \>=30% decrease in sum of target lesion diameter and no new lesions Stable Disease (SD) \- Less than 5 mm increase in target lesion diameter unless it results in a \>=20% increase in diameter and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions Progressive Disease (PD) * \>20% increase in target lesion diameter, must be an absolute increase of 5mm or * Substantial worsening in non-target lesion or * New lesion present
- time origin
- Measured at end of treatment, up to 66 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0002
- source section id
- NCT02113878-om-0002
- source outcome index
- 2
- endpoint
- Median Time to Progression
- endpoint definition
- The median amount of time from baseline to progression and/or death. Patients known to be alive at last contact are censored at last contact. All patients alive at 24 months from baseline are censored at 24 months.
- time origin
- Up to 24 months (Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0003
- source section id
- NCT02113878-om-0003
- source outcome index
- 3
- endpoint
- 24 Month Overall Survival
- endpoint definition
- The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
- time origin
- Up to 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0004
- source section id
- NCT02113878-om-0004
- source outcome index
- 4
- endpoint
- Median Anxiety Score Change
- endpoint definition
- The median change in score on the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire from baseline to cycle 9.GAD-7 has 7 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 21. Higher score represents worse anxiety.
- time origin
- From baseline to cycle 9, up to 66 days.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0005
- source section id
- NCT02113878-om-0005
- source outcome index
- 5
- endpoint
- Median Depression Score Change
- endpoint definition
- The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression.
- time origin
- From baseline to cycle 9, up to 66 days.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 1 and Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Dose Level 1
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dose Level 2
- regimen
- * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02113878-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- harm key
- EG000
- source section id
- NCT02113878-ae
- event group key
- EG000
- event group label
- Dose Level 1
- serious affected
- 17
- serious at risk
- 17
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Measured while on-treatment. From baseline to cycle nine, up to 66 days.
- event definition
- All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docetaxel-5f0ad806
- nct id
- NCT02113878
- harm key
- EG001
- source section id
- NCT02113878-ae
- event group key
- EG001
- event group label
- Dose Level 2
- serious affected
- 6
- serious at risk
- 6
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Measured while on-treatment. From baseline to cycle nine, up to 66 days.
- event definition
- All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice