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Report for Clinical Trial NCT01470209

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.

NCT01470209 Solid Tumors Lung Cancer
MeSH: Lung Neoplasms
HPO: Neoplasm of the lung

2 Interventions

Name: BKM120

Description: BKM120 (20mg to 100mg) will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. BKM120 will be administered on a continuous once daily dosing schedule. Patients should be instructed to take the dose of BKM120 daily in the morning, one hour after a light breakfast (morning meal) at approximately the same time each day. BKM120 should be taken with a glass of water and consumed over as short a time as possible. Patients should swallow the capsules as a whole and not chew them. Patients should continue to fast for 2 hours after the administration of each BKM120 dose.

Type: Drug

Combination of BKM120 and everolimus

Name: Everolimus

Description: RAD001 will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. RAD001 will be administered orally as once daily dose of 5mg or 10 mg (based on the dose cohort) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day.

Type: Drug

Combination of BKM120 and everolimus


Primary Outcomes

Description: i. Grade 4 hematologic toxicity (excluding anemia) lasting more than 7 days ii. Grade 3 anemia lasting more than 7 days or requiring blood transfusion iii. Grade 4 anemia iv. Grade ≥ 3 febrile neutropenia of any duration v. Grade ≥ 3 nausea and or vomiting lasting more than 72 hours in spite of standard supportive therapy vi. Grade ≥ 3 non-hematologic toxicity (excluding alopecia)

Measure: Dose limiting toxicity

Time: During the first cycle of treatment; approximately 4 weeks

Secondary Outcomes

Description: Sum of complete response, partial response and stable disease

Measure: Clinical benefit rate

Time: During the entire duration of therapy estimated to be an average of 6 months for each patient

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

Ability and willingness to undergo repeat tumor biopsies (the biopsy is optional and only applicable to subjects considered for the expansion cohort stage of the study) Exclusion Criteria: 1. Patients who have received prior treatment with a phosphatidylinositol 3-kinase (P13K) inhibitor or RAD001 (if discontinued for toxicity) 2. Patients with a known hypersensitivity to BKM120, RAD001 (including other rapalogs) or their excipients 3. Patients with untreated symptomatic brain metastases are excluded. --- P13K ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8