Experimental drug plus radiation shows promise for recurrent gynecologic cancers
NCT ID NCT03968406
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing the drug talazoparib together with radiation therapy in 24 women whose gynecologic cancer (ovarian, endometrial, cervical, or related cancers) has come back after previous treatment. Talazoparib blocks enzymes that cancer cells need to grow, and radiation uses high-energy X-rays to kill cancer cells. The main goal is to find the safest dose and see if the combination can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Talazoparib (a PARP inhibitor drug) combined with radiation therapy
- What this could lead to
- If it works, this could lead to a new treatment option for women whose gynecologic cancer has returned after prior therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, so the main goal is safety, not proof of effectiveness. The combination may cause significant side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Subjects 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. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks prior to start of investigational therapy * 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 metastases are present in which case it must be =\< 5 x ULN (within 28 days prior to administration of study treatment) * 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 inclusion criteria 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, radiation-induced oophorectomy with last menses \> 1 year ago, chemotherapy-induced menopause with \> 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy) * 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 placement of an intrauterine device (IUD). Acceptable non-hormonal birth control methods include: total sexual abstinence, vasectomized sexual partner plus male condom, tubal occlusion plus male condom with spermicide, IUD plus male condom+spermicide. Acceptable hormonal methods include: etonogestrel implants (i.e. Implanon, Norplan), normal and low dose combined oral pills, norelgestromin/ethinyl estradiol (EE) transdermal system, intravaginal device (i.e. EE and etonogestrel) or cerazette (desogestrel). All of these would need to be combined with male condom with spermicide * 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 magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements * 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 of the study described in this Clinical Study Protocol, so long as they consent to that part Exclusion Criteria: * 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 years (will require discussion with study physician) * 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 resistance protein (BCRP) inhibitors (i.e. elacridar \[GF120918\]) should be avoided. If patients are taking any P-gp inhibitors, P-gp inducers, or BRCP inhibitors, they will need to stop them prior to enrolment on the study * 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 these were started at least 28 days prior to treatment * 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 ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (CT) scan or any psychiatric disorder that prohibits obtaining informed consent * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITINGBaltimore, Maryland, 21287, United States
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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