Trial Outcomes & Findings for Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme (NCT NCT01349660)

Last Updated: 2020-06-17

Results Overview

The optimal dose of BKM120 to administer in combination with standard dose bevacizumab determined as the dose at which ≤1 of 6 patients experiences a DLT assessed using NCI CTCAE v4.03 during Cycle 1 (28 days). The optimal dose of BKM120 was determined to be 60 mg by mouth (PO), once a day for each 28 day cycle along with bevacizumab, administered 10 mg/kg intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

88 participants

Primary outcome timeframe

Collected from day of first dose to the end of the first treatment cycle, up to 28 days

Results posted on

2020-06-17

Participant Flow

Between Oct 2011 and May 2012, 12 participants with refractory solid tumors were enrolled into the Phase I dose escalation trial from 3 U.S. investigational sites. Once a maximum tolerated dose was assigned, from Jul 2012 to Jun 2016, 76 patients with glioblastoma multiforme were enrolled in the Phase II trial from 7 U.S investigational sites

Participant milestones

Participant milestones
Measure	Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Overall Study STARTED	6	6	76
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	6	76

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Overall Study Still Receiving Study Treatment	0	0	1
Overall Study Disease Progression	2	4	50
Overall Study Adverse Event	1	1	12
Overall Study Withdrawal by Subject	2	0	9
Overall Study Death	1	1	0
Overall Study Non-Permitted Interventions	0	0	2
Overall Study Study Compliance	0	0	1
Overall Study Declining Performance Status	0	0	1

Baseline Characteristics

Phase I Outcomes do not utilize prior bevacizumab treatment status, thus number of participants with prior bevacizumab treatment not reported.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Collected from day of first dose to the end of the first treatment cycle, up to 28 days

Population: Includes all Phase I patients receiving assigned study dosing.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab) n=6 Participants Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.	Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=6 Participants Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Number of Phase I Patients Receiving 60mg or 80mg BKM120 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage	0 Participants	3 Participants	—

PRIMARY outcome

Timeframe: every 8 weeks for up to 33 months

Population: All Phase II patients receiving at least one dose of study treatment that have had at least one post-baseline disease assessment

Two groups of patients in the Phase II trial will be considered separately, 1) participants who have not received previous bevacizumab and 2) participants who have received bevacizumab as part of first-line treatment. PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using RANO or McDonald criteria. McDonald disease progression criteria: a 25% or greater increase in sum of the diameters of lesions, new lesions, or clinical deterioration (McDonald et al, 1990). RANO disease progression criteria: a 25% or greater increase in the enhancing lesions sum compared with smallest tumor measurement, significant increase in T2/FLAIR nonenhancing lesion on stable or increasing corticosteroids, new lesions, or clinical deterioration (Wen et al 2010)

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab) n=17 Participants Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.	Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=50 Participants Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Median Progression-Free Survival (PFS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive	2.8 months Interval 1.6 to 5.3	5.3 months Interval 3.6 to 9.2	—

SECONDARY outcome

Timeframe: every 8 weeks, projected 24 months

Population: Includes participants in Phase II that receive at least one study treatment and have at least one post-baseline disease assessment.

Two groups of participants in the Phase II trial will be considered separately, 1) those who have not received previous bevacizumab and 2) those who have received bevacizumab as part of first-line treatment. Overall Response (OR) = number of patients with complete or partial responses (CR or PR) per McDonald or RANO criteria. McDonald: CR as disappearance of all disease for at least four weeks, no new lesions, no steroids; PR as 50% or greater decrease in the sum of all lesions compared with baseline for at least four weeks, no new lesions, stable or reduced steroids (McDonald 1990). RANO: CR as disappearance of all disease for at least 4 weeks, no new lesions, stable or improved nonenhancing lesions, and no steroid usage; and PR as a 50% or greater decrease in the sum of all lesions compared with baseline measurement for at least four weeks, no new lesions, stable or improved nonenhancing lesions on same or lower steroid dose compared to baseline (Wen 2010).

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab) n=17 Participants Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.	Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=50 Participants Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Overall Response (CR or PR) of Phase II Participants - Prior Bevacizumab and Bevacizumab Naive	1 Participants	18 Participants	—

SECONDARY outcome

Timeframe: every 12 weeks for up to 60 months

Population: Participants that have received at least one dose of study treatment

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab) n=19 Participants Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.	Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=57 Participants Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Median Overall Survival (OS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive	6.6 months Interval 4.0 to 14.6	10.8 months Interval 9.2 to 13.5	—

SECONDARY outcome

Timeframe: every 4 weeks for up to 5.2 years

Population: Includes all participants that received at least one dose of study treatment

Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.03

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab) n=6 Participants Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.	Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=6 Participants Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) n=76 Participants BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Necrotizing Fasciitis	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Palsy	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypokalemia	0 Participants	0 Participants	4 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypertension	0 Participants	0 Participants	6 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Asthenia	1 Participants	1 Participants	4 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Aspartate Aminotransferase Increased	0 Participants	0 Participants	5 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypertriglyceridemia	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Muscle Weakness	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Pneumonia	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Sepsis	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Respiratory Failure	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Thrombocytopenia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypercholesterolemia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Mucositis	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Memory Impairment	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Pruritis	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Vomiting	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Mood Alteration	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Weight Loss	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Neutropenia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hemorrhage	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Somnolence	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Taste Alteration	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Agitation	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Dysarthria	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Fall	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypermagnesemia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Ejection Fraction Decreased	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Elevated Liver Enzymes	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypoalbuminemia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hypophosphatemia	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Psychosis	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Suicidal Ideation	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Thromboembolic Event	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Akathisia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Enteritis	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Volume Depletion	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Headache	0 Participants	1 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hyponatremia	0 Participants	0 Participants	3 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Nausea	0 Participants	2 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Proteinuria	0 Participants	0 Participants	3 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Rash	0 Participants	1 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Urinary Tract Infection	0 Participants	2 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Fatigue	1 Participants	0 Participants	8 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Confusion	0 Participants	0 Participants	8 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hyperglycemia	1 Participants	0 Participants	5 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Diarrhea	0 Participants	1 Participants	5 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Alanine aminotransferase increased	0 Participants	1 Participants	5 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Seizure	0 Participants	0 Participants	6 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Abdominal pain	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Altered Mental Status	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Gait Disturbance	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Ataxia	1 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Lipase Increased	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Anorexia	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Dehydration	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Dyspnea	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Cellulitis	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Chronic Obstructive Pulmonary Disease	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Delirium	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Diabetic Ketoacidosis	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Female Genital Tract Fistula	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Gastrointestinal Infection	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Hyperlipidemia	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Intracranial Hemorrhage	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Left Ventricular Systolic Dysfunction	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Paralysis	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Personality Change	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Syncope	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Transaminitis	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Urine Output Decreased	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability Vaginal Fistula	0 Participants	0 Participants	1 Participants

Adverse Events

Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)

Serious events: 27 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Charles Davis, RAC

Sarah Cannon Development Innovations

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Publication restrictions are in place

Restriction type: OTHER

Measure	Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab) n=6 Participants BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab) n=6 Participants BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase I patients include those diagnosed with advanced, metastatic solid tumors.	Phase II - (60 mg BKM120, 10mg/kg Bevacizumab) n=76 Participants BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle. Phase II patients include those with progressive glioblastoma multiforme	Total n=88 Participants Total of all reporting groups
Age, Continuous	61 years n=6 Participants	64 years n=6 Participants	57 years n=76 Participants	57 years n=88 Participants
Sex: Female, Male Female	2 Participants n=6 Participants	2 Participants n=6 Participants	36 Participants n=76 Participants	40 Participants n=88 Participants
Sex: Female, Male Male	4 Participants n=6 Participants	4 Participants n=6 Participants	40 Participants n=76 Participants	48 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=76 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=76 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=76 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	0 Participants n=6 Participants	5 Participants n=76 Participants	5 Participants n=88 Participants
Race (NIH/OMB) White	6 Participants n=6 Participants	6 Participants n=6 Participants	70 Participants n=76 Participants	82 Participants n=88 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=76 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=76 Participants	1 Participants n=88 Participants
Region of Enrollment United States	6 participants n=6 Participants	6 participants n=6 Participants	76 participants n=76 Participants	88 participants n=88 Participants
Primary Tumor Type Glioblastoma Multiforme	2 Participants n=6 Participants	3 Participants n=6 Participants	76 Participants n=76 Participants	81 Participants n=88 Participants
Primary Tumor Type Colorectal	2 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=76 Participants	5 Participants n=88 Participants
Primary Tumor Type Lung	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=76 Participants	2 Participants n=88 Participants
Prior Treatment with Bevacizumab Prior Bevacizumab Treatment	—	—	19 Participants n=76 Participants • Phase I Outcomes do not utilize prior bevacizumab treatment status, thus number of participants with prior bevacizumab treatment not reported.	19 Participants n=76 Participants • Phase I Outcomes do not utilize prior bevacizumab treatment status, thus number of participants with prior bevacizumab treatment not reported.
Prior Treatment with Bevacizumab Bevacizumab Naive	—	—	57 Participants n=76 Participants • Phase I Outcomes do not utilize prior bevacizumab treatment status, thus number of participants with prior bevacizumab treatment not reported.	57 Participants n=76 Participants • Phase I Outcomes do not utilize prior bevacizumab treatment status, thus number of participants with prior bevacizumab treatment not reported.