Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

BKM 120 orally once daily;

Cabazitaxel 25 mg/m2 IV every 3 weeks

BKM 120

Cabazitaxel

John D. Hainsworth, M.D.

Although there have been advances in the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.

This study will be conducted in two parts. In a lead-in cohort, the feasibility and safety of administering BKM120 with a standard dose of cabazitaxel will be assessed. If safety is confirmed, a subsequent Phase II portion will assess the activity of the combination in patients with mCRPC previously treated with docetaxel. The treatment will consist of 3-week (21-day) cycles.

The ultimate purpose of this study will be to determine progression-free survival, response rate, disease control rate and overall survival of patients treated with the combination regimen and compare outcomes to historical results with single-agent cabazitaxel.

Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel

Cabazitaxel With BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer Following Treatment With Docetaxel: Phase II Study With Safety Lead-in Cohort

Determine the optimal dose and safety of BKM120 given with cabazitaxel to patients with metastatic castrate-resistant prostate cancer.

Percentage of complete responders (CR) or partial responders (PR) among patients evaluable for response

Time from first treatment until death from any cause using Kaplan-Meier methods.

Novartis

SCRI Development Innovations, LLC

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

Anti-Infective Agents

Hormones

Letrozole

Sirolimus

Temsirolimus

MTOR Inhibitors

Dactolisib

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

* Dose level 1: 400mg PO BID
* Dose level -1: 400mg PO in AM and 200mg PO in PM
* Dose level -2: 200mg PO BID

BEZ235

* Dose Level 1: BKM120, 100 mg PO daily
* Dose level -1: BKM120, 80 mg PO daily
* Dose Level -2: BKM120, 60 mg PO daily

* Dose Level 1: BKM120, 100 mg PO from Mondays through Fridays, weekly
* Dose level -1: BKM120, 80 mg PO from Mondays through Fridays, weekly
* Dose Level -2: BKM120, 60 mg PO from Mondays through Fridays, weekly

BKM120

Ingrid Mayer, MD

This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with hormone receptor-positive metastatic breast cancer.

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

A Phase Ib Trial of BKM120 (a PI3K Inhibitor) or BEZ235 (a PI3K/mTOR Inhibitor) in Combination With Endocrine Therapy in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

The maximum tolerated dose for each of the arms will be defined as the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels. The first cohort of patients (3 patients) in each arm will be started at dose level 1, and each patient will be observed for 4 weeks on the specified dose.

The overall PFS data will be estimated using the Kaplan-Meier method with the 95% confidence interval. The Cox proportional hazards model will be applied to investigate potential prognostic factors, such as disease free interval after completion of adjuvant endocrine therapy on the time to event data. The adjusted p-values as well as the adjusted 95% confidence intervals from the Cox model will be reported.

All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel	NCT02035124	Advanced Prosta...	BKM 120 Cabazitaxel	18 Years -	SCRI Development Innovations, LLC
Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel	NCT02035124	Advanced Prosta...	BKM 120 Cabazitaxel	18 Years -	SCRI Development Innovations, LLC
PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer	NCT01248494	Metastatic Brea...	BEZ235 BKM 120 Letrozole BKM120	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for bkm 120

Every month we try and update this database with for bkm 120 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bkm 120

Every month we try and update this database with for bkm 120 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bkm 120 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.