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New treatment option for Malignant Female Reproductive System Neoplasm
Official title Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
ClinicalTrials.gov ID: NCT03968406
What this study is testing
What is Talazoparib?
Talazoparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for malignant female reproductive system neoplasm.
Also referred to as BMN 673, BMN-673.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of informed consent prior to any study specific procedures
- Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and...
- people with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy [RT]) is undetectable or...
- Hemoglobin \>= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization (choose whichever is most applicable to the study)...
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within 28 days prior to administration of study treatment)
You likely can't join if
- Ascites, peritoneal carcinomatosis, hepatic metastases
- Prior radiotherapy in the region of planned radiotherapy
- Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
- Previous enrollment in the present study
- Participation in another clinical study with an investigational product during the last 4 weeks
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other...
See the full eligibility criteria
Who can join
- Provision of informed consent prior to any study specific procedures
- Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis
- people with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy [RT]) is undetectable or stable (\>= 3 months) and immediate chemotherapy is not required...
- Hemoglobin \>= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization (choose whichever is most applicable to the study) (within 28 days prior to administration of study treatment)
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within 28 days prior to administration of study treatment)
- No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear (within 28 days prior to administration of study treatment)
- White blood cells (WBC) \> 3 x 10\^9/L (within 28 days prior to administration of study treatment)
- Platelet count \>= 100 x 10\^9/L (within 28 days prior to administration of study treatment)
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional upper limit of normal unless liver...
- Serum creatinine =\< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Note: If cannot fulfill ECOG 0-1, must fulfill below (minimum life expectancy of \>= 16 weeks)
- Patients must have a life expectancy \>= 16 weeks
- Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Postmenopausal is defined as:
- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50...
- Patient of child-bearing potential is willing to adhere to using two forms of highly effective birth control. Condoms with spermicide and one of the following are acceptable: oral contraceptive or hormonal therapy or...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- At least one lesion, not previously irradiated, that can be accurately measured at baseline as \>= 10 mm in the longest diameter (except lymph nodes which must have short axis \>= 15 mm) with computed tomography (CT) or...
- For inclusion in biomarker endpoint, patients must fulfill the following criterion:
- Provision of informed consent for tumor biopsies \ If a patient declines to participate in tumor biopsies, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects...
What rules you out
- Ascites, peritoneal carcinomatosis, hepatic metastases
- Prior radiotherapy in the region of planned radiotherapy
- Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
- Previous enrollment in the present study
- Participation in another clinical study with an investigational product during the last 4 weeks
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \>= 5...
- Patients receiving any systemic chemotherapy, radiotherapy
- Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
- Concomitant use of known P-gp inhibitors (i.e. dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-glycoprotein (P-gp) inducers (i.e. rifampin, tipranavir, ritonavir), or breast cancer...
- Persistent toxicities (\>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) with the exception of alopecia, caused by previous cancer therapy
- Resting electrocardiogram (ECG) with corrected QT (QTc) \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
- Patients with myelodysplastic syndrome/acute myeloid leukemia
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as...
- Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled...
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Breast feeding women
- Patients with a known hypersensitivity to talazoparib or any of the excipients of the product
- Patients with uncontrolled seizures
- Patients requiring pelvic and para-aortic radiotherapy (defined as levels L1/T12)
- Patients with isolated vaginal relapse (i.e. no disease in lymph nodes or else where in pelvis/abdomen)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.