Ovarian CancerPhase 1NCT01623349
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
A Phase 1 study testing BKM120 and Olaparib and BYL719 and Olaparib in people with Ovarian Cancer and Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Breast Cancer
- What is being tested?
- BKM120 and Olaparib and BYL719 and Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2012to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed recurrent high grade serous ovarian cancer or triple negative breast cancer
- Subjects with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within 1 year of completion of adjuvant chemotherapy
- Prior therapy for high grade serous ovarian cancer subjects must have included a first-line platinum-based regimen
- At least 4 weeks since prior radiation therapy, 3 weeks since prior chemotherapy and 6 weeks if the last regimen included BCNU or mitomycin C
- At least 4 weeks since any small-molecular kinase inhibitors or any other type of investigational agent
- Life expectancy of at least 4 months
- Able to swallow and tolerate oral medications
Who cannot join
- Evidence of bowel obstruction, abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of study entry
- Current dependency on IV hydration or total parental nutrition
- Diabetes mellitus unless well controlled
- Pregnant or breast feeding
- History of grade 3 or 4 toxicities with previous PI3kinase inhibitor or PARP inhibitor
- Current or active dermatologic diagnoses that would preclude interpretation of skin toxicities of BKM120
Show all 16Show fewer
- Receiving any medications or substances that are strong inhibitors or inducers of CYP3A4
- History of cardiac dysfunction or disease
- Persistent toxicities (greater than or equal to CTCAE grade 2) caused by previous cancer therapy
- Major surgery within 14 days of starting study treatment
- Evidence of coagulopathy or bleeding diathesis
- History of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, history of suicide attempt or ideation or homicide/homicidal ideation
- CTCAE grade 3 or greater anxiety
- Uncontrolled, intercurrent illness
- Known HIV positive and on combination antiretroviral therapy
- Receiving chronic treatment with steroids or another immunosuppressive agent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
MD Anderson Cancer Center
Houston, Texas, 77230
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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, BYL719 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 the following agents BKM120, BYL719 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 or BYL719 and olaparib is effective in treating your type of cancer.
Read the detailed description
During this study, additional tests will be performed on a sample of your original tumor that has been stored in your institutions tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for your cancer. The research done on these samples will involve looking at DNA and proteins in your cancer to see if researchers can learn more about your type of cancer and understand how this combination of drugs might work on your tumor. Testing of this sample will not require you to undergo any additional research procedures.
Approximately 2 tablespoons of blood will be collected for research testing. This testing will involve looking at DNA and proteins in your blood to compare them with those seen in your cancer. This will be drawn before you begin taking the study drug.
You may also participate in an optional blood test for the BRCA gene. The BRCA gene test is a blood test that uses DNA analysis to see changes in either one of two breast cancer genes, known as BRCA1 or BRCA2. After having a BRCA gene test performed, you learn whether you carry an inherited BRCA gene mutation. If your blood is tested for the BRCA gene, the results will be reported to your study doctor who will share the results with you and provide information related to your personal risk of breast cancer. Having a BRCA gene mutation is rare, occurring in only about 1 in 1000 people. Inherited BRCA gene mutations are responsible for less than 5 to 10 percent of breast cancers and about 10 to 15 percent of ovarian cancers.
Participants in the dose expansion portion of the study may be asked to have a tumor biopsy done. The dose expansion phase for the combination of BKM120 and Olaparib has been determined. The combination of BYL719 and Olaparib is currently in the dose escalation phase and the dose expansion phase has not been determined. Before and after you begin taking BKM120 (or BYL719) and olaparib, your doctor may also ask you to participate in an optional study where you would have tumor biopsies done.
Participation in the tumor biopsy and blood test for the BRCA gene are optional, and whether you consent or refuse to undergo these additional tests will not affect your participation in the main research study.
Since the investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have high grade serious ovarian cancer or triple negative breast cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
All drugs are in oral form. If you take part in this research study, you will be given a study dosing calendar for each drug for each treatment cycle. Each treatment cycle lasts 4 weeks. BKM120 or BYL719 should be taken once daily in the morning, one hour after a light meal. Olaparib should be taken twice a day continuously, about twelve hours apart. The olaparib morning dose should be taken at the same time as BKM120 or BYL719 one hour after a light meal. The evening dose can also be taken one hour after a light meal or on an empty stomach either 1 hour before or 2 hours after meals. If you vomit either or both medications, record this on your diary and do not take another dose that day.
The investigators will assess your tumor by CT or MRI scan every 8 weeks. During Cycle 1, you will come into the clinic every week, and during cycle 2, you will come into clinic every 2 weeks. For all cycles thereafter, you will come in once every 4 weeks.
During study visits you will undergo some or all of the following: evaluation of performance status, recording of any healthy problems, physical exam including vital signs, list of medications taken since last visit, questionnaire to evaluate anxiety and depression, routine blood tests, research blood tests, Electrocardiogram and optional biopsy.
You will remain in this research study as long as you are benefitting from study treatment. If you are removed from the research study for any reason you may be followed for up to one year.
- Conditions
- Ovarian Cancer, Breast Cancer
- Being tested
- BKM120 and Olaparib, BYL719 and Olaparib
- Keywords
- Recurrent, High Grade, Serous, Triple Negative
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120 and OlaparibDrug
Also called Olaparib (NSC 747856), BKM120 (IND 102823)
Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally.
BYL719 and OlaparibDrug
Also called Olaparib (NSC 747856), BYL719 (IND 107078)
Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm BKM | Experimental | BKM120 and Olaparib Receives: Drug: BKM120 and Olaparib |
| Arm BYL | Experimental | BYL719 and Olaparib Receives: Drug: BYL719 and Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD and RP2D of the Combination of BKM120 and Olaparib, and the Combination of BYL719 and Olaparib
To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in patients with recurrent TNBC and HGSC.
Measured: 2 years
Secondary outcomes (4)
Determine the overall Safety and Observed Toxicities of combining BKM120 and Olaparib, and combining BYL719 and Olaparib
To determine the safety and observed toxicities of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in this population
Measured: 2 years
Determine Pharmacokinetics of BKM120 and Olaparib, and BYL719 and Olaparib
To measure the drug levels of both BKM120 and olaparib, and both BYL719 and olaparib at different time points after they are started to see if either drug affects the metabolism and levels of the other. PK samples will be drawn in duplicate (one set to be sent to Astrazeneca and the second set to Novartis). BKM120 (or BYL719) and olaparib levels will be performed at the following timepoints:
- prior to taking both BKM120 (or BYL719) 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.
Measured: 2 years
Determine preliminary activities of these combinations at the MTD and RP2 dose
To determine a preliminary anti-cancer activities of these combinations at the MTD and RP2D dose. Anti-cancer activities of these combinations will be measured by response rate by RECIST 1.1 in patients who have measurable cancer
Measured: 2 years
Exploratory Translational Endpoints
(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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, AstraZeneca
- Responsible party
- Principal investigator, Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
- Investigators
- Ursula A. Matulonis, M.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623349
- Sponsor's protocol ID
- 12-159
- Status last verified
- Feb 2021
- First submitted
- 7 Jun 2012
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batalini F, Xiong N, Tayob N, Polak M, Eismann J, Cantley LC, Shapiro GI, Adalsteinsson V, Winer EP, Konstantinopoulos PA, D'Andrea A, Swisher EM, Matulonis UA, Wulf GM, Mayer EL. Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1493-1499. doi: 10.1158/1078-0432.CCR-21-3045.
PubMed 35149538Chi P, Qin LX, Camacho N, Kelly CM, D'Angelo SP, Dickson MA, Gounder MM, Keohan ML, Movva S, Nacev BA, Rosenbaum E, Thornton KA, Crago AM, Francis JH, Martindale M, Phelan HT, Biniakewitz MD, Lee CJ, Singer S, Hwang S, Berger MF, Chen Y, Antonescu CR, Tap WD. Phase Ib Trial of the Combination of Imatinib and Binimetinib in Patients with Advanced Gastrointestinal Stromal Tumors. Clin Cancer Res. 2022 Apr 14;28(8):1507-1517. doi: 10.1158/1078-0432.CCR-21-3909.
PubMed 35110417Przybytkowski E, Davis T, Hosny A, Eismann J, Matulonis UA, Wulf GM, Nabavi S. An immune-centric exploration of BRCA1 and BRCA2 germline mutation related breast and ovarian cancers. BMC Cancer. 2020 Mar 12;20(1):197. doi: 10.1186/s12885-020-6605-1.
PubMed 32164626Konstantinopoulos PA, Barry WT, Birrer M, Westin SN, Cadoo KA, Shapiro GI, Mayer EL, O'Cearbhaill RE, Coleman RL, Kochupurakkal B, Whalen C, Curtis J, Farooq S, Luo W, Eismann J, Buss MK, Aghajanian C, Mills GB, Palakurthi S, Kirschmeier P, Liu J, Cantley LC, Kaufmann SH, Swisher EM, D'Andrea AD, Winer E, Wulf GM, Matulonis UA. Olaparib and alpha-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial. Lancet Oncol. 2019 Apr;20(4):570-580. doi: 10.1016/S1470-2045(18)30905-7. Epub 2019 Mar 14.
PubMed 30880072
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01623349
- Acronym / sponsor ID
- 12-159
- Conditions
- Ovarian Cancer, Breast Cancer
- Keywords
- Recurrent, High Grade, Serous, Triple Negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Novartis, AstraZeneca
- Study start
- Sep 2012
- Primary completion
- May 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, BYL719 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 the following agents BKM120, BYL719 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 or BYL719 and olaparib is effective in treating your type of cancer.
Detailed description
During this study, additional tests will be performed on a sample of your original tumor that has been stored in your institutions tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for your cancer. The research done on these samples will involve looking at DNA and proteins in your cancer to see if researchers can learn more about your type of cancer and understand how this combination of drugs might work on your tumor. Testing of this sample will not require you to undergo any additional research procedures.
Approximately 2 tablespoons of blood will be collected for research testing. This testing will involve looking at DNA and proteins in your blood to compare them with those seen in your cancer. This will be drawn before you begin taking the study drug.
You may also participate in an optional blood test for the BRCA gene. The BRCA gene test is a blood test that uses DNA analysis to see changes in either one of two breast cancer genes, known as BRCA1 or BRCA2. After having a BRCA gene test performed, you learn whether you carry an inherited BRCA gene mutation. If your blood is tested for the BRCA gene, the results will be reported to your study doctor who will share the results with you and provide information related to your personal risk of breast cancer. Having a BRCA gene mutation is rare, occurring in only about 1 in 1000 people. Inherited BRCA gene mutations are responsible for less than 5 to 10 percent of breast cancers and about 10 to 15 percent of ovarian cancers.
Participants in the dose expansion portion of the study may be asked to have a tumor biopsy done. The dose expansion phase for the combination of BKM120 and Olaparib has been determined. The combination of BYL719 and Olaparib is currently in the dose escalation phase and the dose expansion phase has not been determined. Before and after you begin taking BKM120 (or BYL719) and olaparib, your doctor may also ask you to participate in an optional study where you would have tumor biopsies done.
Participation in the tumor biopsy and blood test for the BRCA gene are optional, and whether you consent or refuse to undergo these additional tests will not affect your participation in the main research study.
Since the investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have high grade serious ovarian cancer or triple negative breast cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
All drugs are in oral form. If you take part in this research study, you will be given a study dosing calendar for each drug for each treatment cycle. Each treatment cycle lasts 4 weeks. BKM120 or BYL719 should be taken once daily in the morning, one hour after a light meal. Olaparib should be taken twice a day continuously, about twelve hours apart. The olaparib morning dose should be taken at the same time as BKM120 or BYL719 one hour after a light meal. The evening dose can also be taken one hour after a light meal or on an empty stomach either 1 hour before or 2 hours after meals. If you vomit either or both medications, record this on your diary and do not take another dose that day.
The investigators will assess your tumor by CT or MRI scan every 8 weeks. During Cycle 1, you will come into the clinic every week, and during cycle 2, you will come into clinic every 2 weeks. For all cycles thereafter, you will come in once every 4 weeks.
During study visits you will undergo some or all of the following: evaluation of performance status, recording of any healthy problems, physical exam including vital signs, list of medications taken since last visit, questionnaire to evaluate anxiety and depression, routine blood tests, research blood tests, Electrocardiogram and optional biopsy.
You will remain in this research study as long as you are benefitting from study treatment. If you are removed from the research study for any reason you may be followed for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm BKM | Experimental | Drug: BKM120 and OlaparibBKM120 and Olaparib |
| Arm BYL | Experimental | Drug: BYL719 and OlaparibBYL719 and Olaparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed recurrent high grade serous ovarian cancer or triple negative breast cancer
- Subjects with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within 1 year of completion of adjuvant chemotherapy
- Prior therapy for high grade serous ovarian cancer subjects must have included a first-line platinum-based regimen
- At least 4 weeks since prior radiation therapy, 3 weeks since prior chemotherapy and 6 weeks if the last regimen included BCNU or mitomycin C
- At least 4 weeks since any small-molecular kinase inhibitors or any other type of investigational agent
Key exclusion criteria (16 listed)
- Evidence of bowel obstruction, abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of study entry
- Current dependency on IV hydration or total parental nutrition
- Diabetes mellitus unless well controlled
- Pregnant or breast feeding
- History of grade 3 or 4 toxicities with previous PI3kinase inhibitor or PARP inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKM120 and OlaparibAlso: Olaparib (NSC 747856), BKM120 (IND 102823)Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally. | Drug | Arm BKM |
| BYL719 and OlaparibAlso: Olaparib (NSC 747856), BYL719 (IND 107078)Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally. | Drug | Arm BYL |
Primary outcome
Determine MTD and RP2D of the Combination of BKM120 and Olaparib, and the Combination of BYL719 and Olaparib
Time frame: 2 years
To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in patients with recurrent TNBC and HGSC.
4 secondary outcomes
Determine the overall Safety and Observed Toxicities of combining BKM120 and Olaparib, and combining BYL719 and Olaparib
Time frame: 2 years
Determine Pharmacokinetics of BKM120 and Olaparib, and BYL719 and Olaparib
Time frame: 2 years
Determine preliminary activities of these combinations at the MTD and RP2 dose
Time frame: 2 years
Exploratory Translational Endpoints
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 35149538Batalini F, Xiong N, Tayob N, Polak M, Eismann J, Cantley LC, Shapiro GI, Adalsteinsson V, Winer EP, Konstantinopoulos PA, D'Andrea A, Swisher EM, Matulonis UA, Wulf GM, Mayer EL. Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1493-1499. doi: 10.1158/1078-0432.CCR-21-3045.
- Derived from this study: PubMed 35110417Chi P, Qin LX, Camacho N, Kelly CM, D'Angelo SP, Dickson MA, Gounder MM, Keohan ML, Movva S, Nacev BA, Rosenbaum E, Thornton KA, Crago AM, Francis JH, Martindale M, Phelan HT, Biniakewitz MD, Lee CJ, Singer S, Hwang S, Berger MF, Chen Y, Antonescu CR, Tap WD. Phase Ib Trial of the Combination of Imatinib and Binimetinib in Patients with Advanced Gastrointestinal Stromal Tumors. Clin Cancer Res. 2022 Apr 14;28(8):1507-1517. doi: 10.1158/1078-0432.CCR-21-3909.
- Derived from this study: PubMed 32164626Przybytkowski E, Davis T, Hosny A, Eismann J, Matulonis UA, Wulf GM, Nabavi S. An immune-centric exploration of BRCA1 and BRCA2 germline mutation related breast and ovarian cancers. BMC Cancer. 2020 Mar 12;20(1):197. doi: 10.1186/s12885-020-6605-1.
- Derived from this study: PubMed 30880072Konstantinopoulos PA, Barry WT, Birrer M, Westin SN, Cadoo KA, Shapiro GI, Mayer EL, O'Cearbhaill RE, Coleman RL, Kochupurakkal B, Whalen C, Curtis J, Farooq S, Luo W, Eismann J, Buss MK, Aghajanian C, Mills GB, Palakurthi S, Kirschmeier P, Liu J, Cantley LC, Kaufmann SH, Swisher EM, D'Andrea AD, Winer E, Wulf GM, Matulonis UA. Olaparib and alpha-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial. Lancet Oncol. 2019 Apr;20(4):570-580. doi: 10.1016/S1470-2045(18)30905-7. Epub 2019 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula A. Matulonis, M.D. principal investigator
Dana-Farber Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BKM120 and Olaparib and BYL719 and Olaparib in people with Ovarian Cancer and Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine MTD and RP2D of the Combination of BKM120 and Olaparib, and the Combination of BYL719 and Olaparib (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623349, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.