BKM120 for Patients With PI3K-activated Tumors
NCT01833169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146
Last updated 2018-10-19
Summary
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Conditions
- PI3K Pathway Activated Tumors
Interventions
- DRUG
-
BKM120
BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-29
- Primary Completion
- 2016-09-26
- Completion
- 2016-09-26
Countries
- United States
Study Locations
More Related Trials
-
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
NCT01708161 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
NCT01576666 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
NCT07054190 ·Status: RECRUITING ·Phase: PHASE2
-
Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents
NCT00790816 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
NCT02058381 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer
NCT01623349 ·Status: COMPLETED ·Phase: PHASE1
-
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
NCT01610284 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating HKI-272 in Tumors
NCT00146172 ·Status: COMPLETED ·Phase: PHASE1
-
AT13387 in Adults With Refractory Solid Tumors
NCT01246102 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
NCT04740918 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
NCT01240655 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
NCT01617668 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
NCT01023204 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
NCT01525589 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
NCT01219699 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
NCT00300781 ·Status: COMPLETED ·Phase: PHASE2
-
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
NCT06726148 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
NCT03872791 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
NCT07306559 ·Status: RECRUITING ·Phase: PHASE1
-
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
NCT01705691 ·Status: COMPLETED ·Phase: PHASE2
-
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
NCT05455619 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
NCT00600275 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
NCT06508216 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors
NCT01831089 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.
NCT03356860 ·Status: COMPLETED ·Phase: PHASE1/PHASE2