A Phase 1 interventional study of BKM120 and Cisplatin in Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma and Hypopharyngeal Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment
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Among 24 studies in Squamous Cell Carcinoma of Head and Neck by Dana-Farber Cancer Institute — 3 open to participants now, 5 under way, none of them phase 3. Squamous Cell Carcinoma of Head and Neck · Dana-Farber Cancer Institute.
Among the 24 studies in Squamous Cell Carcinoma of Head and Neck by Dana-Farber Cancer Institute, this one is the 16th largest by enrollment of the 23 interventional ones that give a count, is the only one that started in 2014, is one of 7 in phase 1, and was the 17th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →3 of the 24 studies in Squamous Cell Carcinoma of Head and Neck by Dana-Farber Cancer Institute are open now, in 1 country. Recruiting first, the newest first:
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 433 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 309 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 14 · Phase 3 1
First in 1995; this study’s year is marked. 1 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 29 across the 23 interventional studies, 150 across the 1 observational. Of the 17 that completed or were terminated, 6 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
2 of the studies in Squamous Cell Carcinoma of Head and Neck by Dana-Farber Cancer Institute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04965792Dana-Farber Cancer InstitutePost-treatment Surveillance in HPV+ Oropharyngeal SCC | 2026-11 |
| NCT06239220Dana-Farber Cancer InstitutePD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 24 studies in Squamous Cell Carcinoma of Head and Neck by Dana-Farber Cancer Institute, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
Drug: BKM120 · Drug: Cisplatin · Radiation: Intensity-modulated radiotherapy (IMRT)
* 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.
Drug: BKM120 · Drug: Cisplatin · Radiation: Intensity-modulated radiotherapy (IMRT)
BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Also known as: Buparlisib
Cisplatin is a chemotherapy drug
Also known as: Platinol-AQ, Platinol
IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
Also known as: IMRT
Maximum Tolerated Dose of Cisplatin
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
Time frame: While on treatment, up to 66 days
Maximum Tolerated Dose of BKM120
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
Time frame: While on treatment, up to 66 days
Best Overall Response
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 frame: Measured at end of treatment, up to 66 days
Median Time to Progression
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 frame: 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)
24 Month Overall Survival
The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
Time frame: Up to 24 months
Median Anxiety Score Change
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 frame: From baseline to cycle 9, up to 66 days.
Median Depression Score Change
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 frame: From baseline to cycle 9, up to 66 days.
P13K Status by Response
Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR).
Time frame: Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days.
September 29, 2014-December 5, 2017
| Milestone | Dose Level 1 | Dose Level 2 |
|---|---|---|
| Started | 17 | 6 |
| Completed | 14 | 6 |
| Not completed | 3 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Patient non-compliance | 1 | 0 |
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
| mg/m2 | Dose Level 1 and Dose Level 2 |
|---|---|
| Maximum Tolerated Dose of Cisplatin | 30 |
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
| Participants | Dose Level 1 | Dose Level 2 |
|---|---|---|
| Complete Response | 6 | 2 |
| Partial Response | 6 | 2 |
| Stable Disease | 0 | 1 |
| Progressive Disease | 3 | 0 |
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.
| months | Dose Level 1 | Dose Level 2 |
|---|---|---|
| Median Time to Progression | 14.5 (13.3 to 22.8) | NA (NA to NA) |
The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
| probability of survival | Dose Level 1 | Dose Level 2 |
|---|---|---|
| 24 Month Overall Survival | 0.929 (0.591 to 0.99) | 0.240 (0.239 to 0.246) |
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.
| points | Dose Level 1 | Dose Level 2 |
|---|---|---|
| Median Anxiety Score Change | -0.5 (-5 to 6) | 0 (-3 to 1) |
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.
| points | Dose Level 1 | Dose Level 2 |
|---|---|---|
| Median Depression Score Change | 1 (-4 to 9) | 0 (-8 to 0) |
Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR).
| Participants | Dose Level 1 | Dose Level 2 |
|---|---|---|
| P13K Positive - Responder | 2 | 1 |
| P13K Positive - Non-Responder | 1 | 1 |
| P13K Negative - Responder | 9 | 1 |
| P13K Negative - Non-Responder | 3 | 1 |
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
| mg | Dose Level 1 and Dose Level 2 |
|---|---|
| Maximum Tolerated Dose of BKM120 | 40 |
Collected over Measured while on-treatment. From baseline to cycle nine, up to 66 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1 | 1/17 (5.9%) | 17/17 (100%) | — |
| Dose Level 2 | 1/6 (16.7%) | 6/6 (100%) | — |
| Event | Dose Level 1 | Dose Level 2 |
|---|---|---|
| AnorexiaMetabolism and nutrition disorders | 12/17 | 6/6 |
| Dermatitis radiationInjury, poisoning and procedural complications | 10/17 | 6/6 |
| Dry mouthGastrointestinal disorders | 9/17 | 6/6 |
| DysgeusiaNervous system disorders | 11/17 | 6/6 |
| Mucositis oralGastrointestinal disorders | 15/17 | 6/6 |
| Weight lossInvestigations | 2/17 | 6/6 |
| FatigueGeneral disorders and administration site conditions | 9/17 | 5/6 |
| NauseaGastrointestinal disorders | 12/17 | 5/6 |
| ConstipationGastrointestinal disorders | 12/17 | 4/6 |
| HyperglycemiaMetabolism and nutrition disorders | 9/17 | 4/6 |
| Age, Continuous(years) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Mean | 63.7 ± 7.1 | 57.2 ± 4.17 | 62.0 ± 7.02 |
| Sex: Female, Male(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 14 | 5 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 15 | 6 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 16 | 6 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Stage(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Clinical Cancer Stage 3 | 0 | 2 | 2 |
| Clinical Cancer Stage 4 | 17 | 4 | 21 |
| Primary Disease Site(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Hypopharynx | 1 | 0 | 1 |
| Oral Cavity | 4 | 2 | 6 |
| Oropharynx | 11 | 1 | 12 |
| Larynx | 0 | 3 | 3 |
| Oth | 1 | 0 | 1 |
| Smoking History(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Yes | 17 | 6 | 23 |
| No | 0 | 0 | 0 |
| Number of Pack Years(Participants) | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|
| Greater than 10 | 17 | 5 | 22 |
| Less than or equal to 10 | 0 | 1 | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There are no plans to share the IPD. Cumulative data will be published however.
Ran from Sep 2014 to primary completion in Dec 2019, 62 months.
Results were first posted in Nov 2024, 4 years 10 months after primary completion.
Of 114 non-industry phase 1 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 61. This study's 62 months is above that.
Counting every sponsor, half of 268 studies reached it within 49 months; a quarter within 33 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buparlisib
Squamous Cell Carcinoma of Head and Neck →
Dana-Farber Cancer Institute →