PARP Inhibitor BMN-673 in Determining Genetic Effects on Disease Response in Patients with Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This trial is active, not recruiting.
|Conditions||fallopian tube cancer, ovarian cancer, peritoneal cancer|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||June 2015|
|End date||June 2018|
|Trial size||30 participants|
|Trial identifier||NCT02316834, 2014-0474, NCI-2014-02608, SP50CA083639|
The goal of this clinical research study is to learn about the effects of BMN 673 on ovarian, Fallopian tube, and peritoneal cancer. Researchers want to find out if certain characteristics of the DNA (the genetic material in cells) affect how the disease responds to therapy with BMN 673 and if treatment with BMN 673 affects the genetic material in cancer cells.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Changes in DNA Copy Number Before and After Treatment with BMN 673
time frame: 28 days
Change in RNA Protein Expression Before and After Treatment with BMN 673
time frame: 28 days
Feasibility of Treatment with BMN 673: 70% of patients complete all planned doses of BMN 673 and post-operative chemotherapy
time frame: 28 days
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated CA125, and/or ovarian mass(es), or at the discretion of the treating physician. 2. Medically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physician. 3. No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma. 4. Patients must be able to swallow and tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of BMN 673 (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome; ulcerative disease) 5. Patients must have normal organ and marrow function (measured within 28 days prior to entry/ randomization) as defined below: a. Absolute neutrophil count >/= 1,500/mcL b. Hemoglobin>/= 9gm/dL c. Platelets >/= 100,000/mcL d. Total Bilirubin = 1.5X ULN e. AST/ALT = 2.5x upper limit of normal unless the liver is involved with tumor, in that case, ALT/AST must be = 5x upper limit of normal f. Creatinine clearance >/= 50 mL/min (assessed by Cockcroft Gault estimation) 6. Patients must have an ECOG performance status of 0 or 1 7. The effects of BMN 673 on the developing human fetus are unknown. For this reason, women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 30 days after the last dose of study medication. Women of child-bearing potential (intact uterus) should have a negative serum pregnancy test. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 8. Cont. form #7. Female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: － Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments － Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation. Male partners should be instructed to use contraception during the study period. 9. It is unknown if BMN 673 is expressed in human breast milk. For this reason, women must not breast-feed while taking the study medications. 10. Patients must be able to understand and willing to sign an informed consent. 11. Patients must be at least 18 years of age. Exclusion Criteria: 1. Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer. 2. Receipt of any other investigational agents or any additional anti-cancer agents. 3. Significant symptom burden from presumed diagnosis including large volume ascites, pain requiring narcotic medication, or shortness of breath on exertion. 4. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication. 5. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >/= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. 6. As judged by the Investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
|Official title||POSITION: A PilOt Study of InducTion PARP InhibitiON in Ovarian Cancer|
|Principal investigator||Shannon N. Westin, MD|
|Description||Study Drug Administration: If participant is eligible to continue the study, they will begin taking BMN 673 tablets by mouth every day, starting on the day of their scheduled laparoscopy. Participant will take the study drug for at least 7 days before their scheduled tumor reduction surgery. Participant will stop taking the drug on the day of the surgery and during their recovery time. Once participant has recovered from surgery (about 3-6 weeks later), they will receive standard chemotherapy treatment. The chemotherapy is part of participant's standard of care treatment and is not part of this research study. The type of chemotherapy participant receives will be up to their doctor. The tablets should be taken either 2 hours before or 2 hours after meals. If participant vomits after taking their daily dose of BMN 673, they should not retake the dose. Participant should wait until their next scheduled dose, the next day. Participant will need to record when they take each dose in a study drug diary. The study drug diary will be provided by the study staff, and they will show participant how to fill it out. Study Visits: On the day of participant's screening visit, blood (about 1-2 teaspoons) will be drawn for routine tests as part of their standard clinical care. Part of this sample will also be used for the genetic research tests described above. On the day of participant's laparoscopy, the following procedures will be performed for this study: - At least 4 fresh samples of tumor tissue (1 x 1 cm tissue section) will be collected for research purposes during the laparoscopic exam. Tissue may be collected from the ovary (2 samples), peritoneum, omentum, diaphragm, or other sites. All samples will be stored at the MD Anderson Gynecologic Oncology Tumor Bank. Participant's samples will be stored under a unique identifier known to only authorized members of the study team. The assigned unique identifier will ensure protection of participant's private health information. Samples will be stored at the MD Anderson Gynecologic Oncology Tumor Bank indefinitely. On the day of participant's pre-operative visit, they will only have routine tests. Blood (about 1-2 teaspoons) will be drawn for routine tests as part of participant's standard clinical care. Part of this sample will also be used for the genetic research tests described above. On the day of participant's surgery, the following procedures will be performed for this study: - At least 4 fresh samples of tumor tissue (1 x 1 cm tissue section) will be collected for research purposes during the laparoscopic exam. Tissue may be collected from the ovary (2 samples), peritoneum, omentum, diaphragm, or other sites. All samples will be stored at the MD Anderson Gynecologic Oncology Tumor Bank. Participant's samples will be stored under a unique identifier known to only authorized members of the study team. The assigned unique identifier will ensure protection of participant's private health information. Samples will be stored at the MD Anderson Gynecologic Oncology Tumor Bank indefinitely. On the day of participant's post-operative visit, they will only have routine tests performed as part of their standard clinical care. Length of Treatment: Participant may take the study drug for up to 28 days, as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the study drug if intolerable side effects occur, they are not eligible for treatment/surgery, or they are unable to follow study directions. Patient's participation on the study will be over after the follow-up visits. Follow-Up: Participant may be asked to come to the clinic for a follow-up visit 30 days after the tumor reduction surgery. At this visit, blood (about 1-2 teaspoons) will be drawn for routine tests as part of participant's standard clinical care. Part of this sample will also be used for the genetic research tests described above. Participant's health status will be followed with information collected during their routine clinic visits every 3 months after stopping the study drug. If participant had to stop taking BMN 673 because of side effects, the study staff will follow up with them until the side effects go away. This is an investigational study. BMN 673 is not FDA approved. At this time, it is being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 30 participants will take part in this research study. All will be enrolled at MD Anderson.|
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