Phase I of BKM120/Olaparib for Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination to use for further studies. "Investigational" means that the combination of these drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved either of these drugs nor the combination of being tested for use in patients, including people with your type of cancer.
BKM120 and olaparib are drugs that may stop cancer cells from growing abnormally. These drugs when combined in laboratory experiments with animals, have demonstrated anti-cancer activity. Information from these other research studies suggests that both of these agents BKM120 and olaparib, may help to shrink tumor cells in the types of cancers being studied in this research study.
In this research study, the investigators are looking for the highest dose that can be given safely and also to see if the combination of BKM120 and olaparib is effective in treating your type of cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of the Oral PI3kinase Inhibitor BKM120 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or Recurrent High Grade Serous Ovarian Cancer|
- Determine MTD for the Combination of BKM120 and Olaparib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib in patients with recurrent TNBC and HGSC.
- Determine the overall Safety and Observed Toxicities of combining BKM120 and Olaparib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine the safety and observed toxicities of the combination of BKM120 and olaparib in this population
- Determine Pharmacokinetics of BKM120 and Olaparib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To measure the drug levels of both BKM120 and olaparib at different time points after they are started to see if either drug affects the metabolism and levels of the other. PK's samples will be drawn in duplicate (one set to be sent to Astrazeneca and the second set to Novartis). BKM120 and olaparib levels will be performed at the following timepoints:
- prior to taking both BKM120 and olaparib cycle 1, day 1.
- Cycle 1, day 8: prior to dosing, 1, 2, 4, and 8 hours post am dosing.
- Cycle 1, day 15: prior to dosing, 1, 2, 4, and 8 hours post am dosing.
- Determine preliminary activity of this combination at the MTD and RP2 dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine a preliminary anti-cancer activity of this combination at the MTD and RP2D dose. Anti-cancer activity of this combination will be measured by response rate by RECIST 1.1 in patients who have measurable cancer
- Exploratory Translational Endpoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]
(A) To determine the downstream signaling effects of the PI3-kinase pathway whenboth PI3-kinase and PARP are inhibited.
(B) To determine BRCA1 immnostaining, BRCA1 promoter hypermethylation and somatic mutations in BRCA1 and BRCA2 in archived formalin fixed paraffin embedded (FFPE) tissue and any new available tissues (pre- or post-treatment biopsies and biopsies or other tumor colelction for clinical care at the time of or following tumor progression)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
BKM120 and Olaparib
Drug: BKM120 and Olaparib
Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01623349
|Contact: Christin Whalen, RNemail@example.com|
|Contact: Philippa Quyfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Susan McIntyre 617-667-1940 email@example.com|
|Contact: Aaron Weitz 617-667-5987 firstname.lastname@example.org|
|Principal Investigator: Gerburg Wulf, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Christin Whalen, RN 617-582-7738 email@example.com|
|Contact: Kristin Meegan 617-632-6617 firstname.lastname@example.org|
|Principal Investigator: Ursula Matulonis, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Tina Atkinson 617-643-5150 email@example.com|
|Principal Investigator: Michael Birrer, MD, PhD|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York City, New York, United States, 10065|
|Contact: Katherine Bell-McGuinn, MD 646-888-4221 firstname.lastname@example.org|
|Principal Investigator: Katherine Bell-McGuinn, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77230|
|Contact: Shannon Westin, MD 713-794-4314|
|Principal Investigator: Shannon Westin, MD|
|Principal Investigator:||Ursula A. Matulonis, M.D.||Dana-Farber Cancer Institute|