Prostate CancerPhase 1NCT01741753
BKM120+Abiraterone Acetate for Metastatic CRPC
A Phase 1 study testing BKM120, Abiraterone and Prednisone in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 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 drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BKM120, Abiraterone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to 1 Sep 2016
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed CRPC with metastatic bone disease
- Castrate resistant disease
- Life expectancy of at least 6 months
- At least four weeks from previous treatment
- At least four weeks since any major surgery or radiation therapy
- Using highly effective contraception
Who cannot join
- Thromboembolism within past 6 months
- History of diabetes
- Prior therapy with abiraterone
- Prior therapy with PI3K inhibitor
- Alcohol or drug dependence currently or within past 6 months
- Contraindications to biopsy, such as bleeding disorders
Show all 17Show fewer
- On anticoagulants such as warfarin or heparin
- Active malignancy other than skin cancer or superficial bladder cancer
- Untreated brain metastases
- Acute or chronic liver, renal disease or pancreatitis
- Mood disorders judged by the investigator to interfere with study participation
- Active cardiac disease or history of cardiac dysfunction
- Uncontrolled hypertension
- Known HIV, Hepatitis B or C
- Serious non-healing wound, ulcer or bone fracture
- Known or suspected allergy to BKM120, abiraterone or prednisone
- Impairment of GI function
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer.
BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer.
Read more
Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone.
Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.
Read the detailed description
You will undergo a screening process to determine if you are eligible to participate in this trial. This process will include the following procedures: Tumor Biopsy, including a bone marrow biopsy, which is used to determine the kinds of cancer cells in your tumor and a Physical Examination, including weight, blood pressure, heart rate, respiratory rate and body temperature.
Since we 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 docetaxel resistant CRPC, 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.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. There will be a 14 day lead in phase of BKM120 alone to assess for toxicity from this agent. After the lead in phase, the standard dose of abiraterone and prednisone will be added to the BKM120 treatment regimen. Treatment cycles will last 4 weeks (28 days), during which time you will be taking the study drug in combination with the standard drug therapy once daily. Your time of participation in the study will be based on how well you tolerate the experimental drug. You could be participating in the study for a period of days, or years, depending on the course of your cancer.
During each treatment cycle, you will be required to return to see your research doctor for a study visit on Day 1 of each cycle. For Cycle 1, you will also need to return on Days 8, 15 and 22.
The following procedures will be performed and samples will be collected at 1 or more study visits: Evaluation of side effects, Vital sign measurement, Heart function tests, Neuropsychologic exams, Performance status assessment, Tumor biopsy, Assessment of tumor, Blood samples.
We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year will help us look at the long-term effects of the research study. You will be required to return to see your research doctor for an end of study visit, which will take place 4-8 weeks after you undergo prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- BKM120, Abiraterone, Prednisone
- Keywords
- Docetaxel Pretreated, Castrate Resistant, Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120Drug
Orally, every morning
AbirateroneDrug
Orally, 1000 mg, every morning
PrednisoneDrug
Orally, 5 mg, every morning
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | BKM120+Abiraterone+Prednisone Receives: Drug: BKM120; Drug: Abiraterone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile and MTD for BKM120/Abiraterone/Prednisone
Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone
Measured: 2 years
Secondary outcomes (2)
Duration of Response in Expansion Cohort
Determine duration time of response (time to progression) in the expansion cohort
Measured: 2 years
Impact of PTEN Status on Response Rate/Duration
Assess the impact of PTEN status on response rate and duration of response
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 posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completion29 Dec 2014
- Study completion1 Sep 2016
Why it stopped: Due to slow accrual the supllier of BKM120 asked we cease further enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Bubley, MD, Dana-Farber Cancer Institute
- Investigators
- Glenn Bubley, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741753
- Sponsor's protocol ID
- 12-121
- Status last verified
- Feb 2019
- First submitted
- 3 Dec 2012
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT01741753
- Acronym / sponsor ID
- 12-121
- Conditions
- Prostate Cancer
- Keywords
- Docetaxel Pretreated, Castrate Resistant, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual the supllier of BKM120 asked we cease further enrollment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 29 Dec 2014 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 5 Dec 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 drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer.
BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer.
Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone.
Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.
Detailed description
You will undergo a screening process to determine if you are eligible to participate in this trial. This process will include the following procedures: Tumor Biopsy, including a bone marrow biopsy, which is used to determine the kinds of cancer cells in your tumor and a Physical Examination, including weight, blood pressure, heart rate, respiratory rate and body temperature.
Since we 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 docetaxel resistant CRPC, 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.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. There will be a 14 day lead in phase of BKM120 alone to assess for toxicity from this agent. After the lead in phase, the standard dose of abiraterone and prednisone will be added to the BKM120 treatment regimen. Treatment cycles will last 4 weeks (28 days), during which time you will be taking the study drug in combination with the standard drug therapy once daily. Your time of participation in the study will be based on how well you tolerate the experimental drug. You could be participating in the study for a period of days, or years, depending on the course of your cancer.
During each treatment cycle, you will be required to return to see your research doctor for a study visit on Day 1 of each cycle. For Cycle 1, you will also need to return on Days 8, 15 and 22.
The following procedures will be performed and samples will be collected at 1 or more study visits: Evaluation of side effects, Vital sign measurement, Heart function tests, Neuropsychologic exams, Performance status assessment, Tumor biopsy, Assessment of tumor, Blood samples.
We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year will help us look at the long-term effects of the research study. You will be required to return to see your research doctor for an end of study visit, which will take place 4-8 weeks after you undergo prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: BKM120, Drug: Abiraterone, Drug: PrednisoneBKM120+Abiraterone+Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed CRPC with metastatic bone disease
- Castrate resistant disease
- Life expectancy of at least 6 months
- At least four weeks from previous treatment
- At least four weeks since any major surgery or radiation therapy
Key exclusion criteria (17 listed)
- Thromboembolism within past 6 months
- History of diabetes
- Prior therapy with abiraterone
- Prior therapy with PI3K inhibitor
- Alcohol or drug dependence currently or within past 6 months
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 |
|---|---|---|
| BKM120Orally, every morning | Drug | Treatment Arm |
| AbirateroneOrally, 1000 mg, every morning | Drug | Treatment Arm |
| PrednisoneOrally, 5 mg, every morning | Drug | Treatment Arm |
Primary outcome
Safety Profile and MTD for BKM120/Abiraterone/Prednisone
Time frame: 2 years
Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone
2 secondary outcomes
Duration of Response in Expansion Cohort
Time frame: 2 years
Impact of PTEN Status on Response Rate/Duration
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Due to slow accrual the supllier of BKM120 asked we cease further enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Beth Israel Deaconess Medical Center Cancer Clinical Trials Office.Link provided by the sponsor.
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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.
Glenn Bubley, MD principal investigator
Beth Israel Deaconess Medical Center
2 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, Abiraterone and Prednisone in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Due to slow accrual the supllier of BKM120 asked we cease further enrollment.). Results are not available in the source record.
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?
Safety Profile and MTD for BKM120/Abiraterone/Prednisone (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.