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Talazoparib + Radiation for Gynecologic Cancers
Phase 1
Recruiting
Led By Lilie L Lin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at the side effects and best dose of talazoparib when given with radiation therapy for treating patients with recurrent gynecologic cancers. Talazoparib may stop cancer growth by blocking some enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib with radiation therapy may work better in treating patients with gynecologic cancers.
Who is the study for?
This trial is for patients with certain types of recurrent gynecologic cancers, including ovarian, fallopian tube, primary peritoneal, endometrial, vaginal or cervical cancer. Participants must have adequate blood counts and organ function and not be pregnant or breastfeeding. They should agree to use effective birth control if applicable and not have any serious medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the combination of a drug called Talazoparib with radiation therapy to see how well they work together in treating recurrent gynecologic cancers. The goal is to determine the best dose of Talazoparib when used with radiation therapy and assess their effectiveness.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin irritation and fatigue as well as those related to Talazoparib which may involve blood cell count changes, nausea, vomiting, hair loss (alopecia), and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and has not been treated with radiation.
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My liver function tests are within the required range.
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I am fully active or can carry out light work.
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My hemoglobin is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.
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My cancer is in the abdomen or pelvis and has come back after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Incidence of adverse events
Local control rate
Overall survival
+3 moreOther outcome measures
Expanded Prostate Cancer Index Composite (EPIC)
Functional Assessment of Cancer Therapy (FACT)
Gamma-H2AX and RAD51 foci formation levels
+2 moreSide effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT0211677789%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Hypokalemia
22%
Cough
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Weight loss
11%
Periorbital infection
11%
Bone pain
11%
Allergic reaction
11%
Tumor pain
11%
Febrile neutropenia
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (talazoparib, radiation therapy)Experimental Treatment3 Interventions
Patients receive talazoparib PO QD beginning on days -10 to -7 and continuing for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy 5 days a week (Monday-Friday) for up to 7 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,411 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,745 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,830 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Lilie L LinPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
648 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications like ketoconazole or ritonavir.I have a tumor that can be measured and has not been treated with radiation.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.Your recent blood test does not show signs of a specific type of blood disorder called myelodysplastic syndrome or acute myeloid leukemia.Your serum creatinine level is not more than 1.5 times the upper limit of normal.My cancer has returned in the vagina only, with no spread to lymph nodes or elsewhere.I have not had major surgery in the last 2 weeks or have fully recovered from it.My stage IV cancer is stable or undetectable outside the radiation area, and I can stop other treatments 3 weeks before starting the trial.I have lasting side effects from cancer treatment, but not hair loss.I am currently undergoing chemotherapy or radiotherapy.I have fluid in my abdomen, cancer spread in my abdomen lining, or liver metastases.I haven't had cancer treatments or experimental drugs in the last 3 weeks.I have had another type of cancer but it was treated successfully and I've been disease-free for over 5 years.I cannot swallow pills or have a stomach condition that affects medication absorption.I am not pregnant, cannot become pregnant, or am following strict birth control measures.My cancer is in the abdomen or pelvis and has come back after treatment.I do not have any serious uncontrolled health issues or infections.My liver function tests are within the required range.I am fully active or can carry out light work.I am willing and able to follow the study's treatment plan and attend all visits.My hemoglobin is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.I have brain metastases but they are under control and I've been on a stable dose of corticosteroids for at least 28 days.Your white blood cell count is higher than 3 x 10^9/L in the last 28 days before starting the study treatment.Your total bilirubin level must be less than 1.5 times the upper limit of normal at the hospital where you are being treated.Your platelet count is at least 100 billion per liter within the last 28 days before starting the study treatment.I have seizures that are not controlled by medication.I am not taking any medications that affect drug transport in the body.My ECG shows a QTc over 470 msec or I have a family history of long QT syndrome.I need radiotherapy in my pelvic and lower back area.You are expected to live for at least 16 weeks.Your white blood cell count is normal.You are allergic to talazoparib or any of the ingredients in the product.I have had radiotherapy in the same area where more is planned.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talazoparib, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this clinical exploration?
"Affirmative, the data available on clinicaltrials.gov suggests that this medical experiment is currently enrolling patients. Initially posted on September 26th 2019 and most recently edited June 6th 2022, 24 subjects are being sought from a single facility."
Answered by AI
Has the FDA sanctioned Talazoparib for widespread use?
"The safety of Talazoparib is estimated to be a 1, as this trial is only in its preliminary stages. There exists limited data on both the efficacy and safety at this time."
Answered by AI
Is this study actively enlisting participants at the present time?
"Affirmative. According to the information readily available on clinicaltrials.gov, this study is actively seeking participants. The research was first posted in September 2019 and underwent its last edit in June 2022. 24 individuals are needed for enrolment at one medical facility."
Answered by AI
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