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Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer

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 teh 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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Profile and MTD for BKM120/Abiraterone/Prednisone

Outcome Description:

Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

September 2016

Related Keywords:

  • Prostate Cancer
  • Docetaxel Pretreated
  • Castrate Resistant
  • Metastatic
  • Prostatic Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Beth-Israel Deaconess Medical CenterBoston, Massachusetts