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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)

Must not have

Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

Patients with myelodysplastic syndrome/acute myeloid leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications like ketoconazole or ritonavir.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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My cancer has returned in the vagina only, with no spread to lymph nodes or elsewhere.

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I have not had major surgery in the last 2 weeks or have fully recovered from it.

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I am currently undergoing chemotherapy or radiotherapy.

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I have fluid in my abdomen, cancer spread in my abdomen lining, or liver metastases.

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I do not have any serious uncontrolled health issues or infections.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have seizures that are not controlled by medication.

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I am not taking any medications that affect drug transport in the body.

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My ECG shows a QTc over 470 msec or I have a family history of long QT syndrome.

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I need radiotherapy in my pelvic and lower back area.

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I have had radiotherapy in the same area where more is planned.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Incidence of adverse events

Local control rate

Overall survival

+3 more

Other study objectives

Expanded Prostate Cancer Index Composite (EPIC)

Functional Assessment of Cancer Therapy (FACT)

Gamma-H2AX and RAD51 foci formation levels

+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Muscle weakness lower limb

33%

Fever

33%

Peripheral sensory neuropathy

33%

Creatinine increased

33%

Lymphocyte count decreased

33%

Pain in extremity

33%

Weight loss

33%

Hyponatremia

33%

Hypoglycemia

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Skin infection

33%

Nervous system disorders - Other, PARALYSIS

33%

Hypokalemia

33%

Insomnia

33%

Sinus tachycardia

33%

Alanine aminotransferase increased

33%

Peripheral motor neuropathy

33%

Diarrhea

33%

Hypermagnesemia

33%

Hypophosphatemia

33%

Gastroesophageal reflux disease

33%

Skin ulceration

33%

Cough

33%

Non-cardiac chest pain

33%

Scoliosis

33%

Urinary incontinence

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Hypertension

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Constipation

33%

Alopecia

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Investigations - Other, ALT DECREASED

33%

Hypothyroidism

33%

Nausea

33%

Investigations - Other, BUN DECREASED

33%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/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 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Radiation Therapy

2017

Completed Phase 3

~7250

Talazoparib

2021

Completed Phase 2

~2810