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PARP Inhibitor

Talazoparib + Temozolomide for Advanced Rare Cancers

Phase 2
Recruiting
Led By A P Chen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior to entering the study, patients must have: >= 3 weeks since completion of radiation therapy or major surgery, >= 5 half-lives or 3 weeks (whichever is shorter) since completion of biologic therapy or chemotherapy, should be at least 6 weeks out from nitrosoureas and mitomycin C, >= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study, >= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion), recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted, adults age >= 18 years; children/adolescents age >= 12 years to 17 years with body surface area (BSA) >= 1.5 m^2, Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%), absolute neutrophil count >= 1,500/mcL, platelets >= 100,000/mcL, hemoglobin >= 8 g/dL, total bilirubin =< 1.5 X institutional upper limit of normal (=< 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline), aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X upper limit of normal (ULN), creatinine clearance >= 60 mL/min/1.73 m^2 OR creatinine for adult patients: =< 1.5 X institutional ULN, for pediatric patients (< 18 years of age): 2 to < 6 years (0.8 mg/dL male, 0.8 mg/dL female), 6 to < 10 years (1 mg/dL male, 1 mg/dL female), 10 to < 13 years (1.2 mg/dL male, 1.2 mg/dL female), 13 to < 16 years (1.5 mg/dL male, 1.4 mg/dL female), 16 to < 18 years (1.7 mg/dL male, 1.4 mg/dL female), talazoparib and temozolomide can cause fetal harm based on animal reproductive and genetic toxicity studies. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 7 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study drug administration. Women of child-bearing potential must have a negative pregnancy test (urine or serum) in the 8 days prior to beginning treatment, and again on cycle 1 day 1 of treatment, biopsies are optional on this study. In lieu of baseline biopsies, patients are encouraged to submit at registration archival tumor biopsy tissue from a previous research study or medical care providing it meets the minimum collection and preservations requirements. Criteria for the submission of archival tissue are: tissue must have been collected within 3 months prior to registration, patient must not have received any intervening therapy for their cancer since the collection of the tumor sample, human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For these patients, an HIV viral load test must be completed within 28 days prior to enrollment, patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better, ability to understand and the willingness to sign a written informed consent document
Patients must have histologically confirmed rare solid tumors that have progressed on standard therapy or for whom there is no longer standard of care therapy. Other rare tumor types may be acceptable at the discretion of the principal investigator (PI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from study enrollment
Awards & highlights

Study Summary

This trial is testing whether a combination of two drugs, talazoparib and temozolomide, can shrink tumors in patients with rare cancers that have spread to other parts of the body.

Who is the study for?
Adults and adolescents with advanced rare cancers, including paraganglioma and pheochromocytoma, who have progressed on standard therapy or lack further standard care options. Participants need measurable disease per RECIST v1.1 criteria, adequate organ function, no eligibility for higher priority trials, and must agree to contraception due to potential fetal harm from the drugs.Check my eligibility
What is being tested?
The RARE 2 trial is testing a combination of talazoparib (a PARP inhibitor that prevents cancer cells from repairing DNA damage) and temozolomide (an alkylating agent that damages cancer cell DNA), aiming to shrink tumors in patients with advanced stage rare cancers.See study design
What are the potential side effects?
Potential side effects include fatigue, digestive issues like nausea or constipation, blood disorders such as low counts of white cells or platelets which can increase infection risk or cause bleeding problems respectively. There may also be liver function changes and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My rare solid tumor has worsened despite treatment, or there are no standard treatments left for me.
Select...
I am not eligible for higher priority studies due to previous treatments.
Select...
I agree to a biopsy and my tumor can be safely biopsied.
Select...
I have a tumor that can be measured by standard criteria.
Select...
It's been over 3 weeks or 5 half-lives since my last chemo or biologic therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response
Other outcome measures
Genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA) and circulating tumor cells (CTCs)
Genomic and transcriptomic determinants of response and resistance
Pharmacodynamic effects of the combination on biomarkers of cell death and epithelial-to-mesenchymal transition in tumor tissue and CTCs
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
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%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Allergic reaction
11%
Weight loss
11%
Tumor pain
11%
Febrile neutropenia
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Bone pain
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, temozolomide)Experimental Treatment5 Interventions
Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and may optionally undergo biopsy and/or blood sample collection at baseline and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~840
Biospecimen Collection
2004
Completed Phase 2
~1920
Temozolomide
2010
Completed Phase 3
~1930
Computed Tomography
2017
Completed Phase 2
~2790
Talazoparib
2021
Completed Phase 2
~2770

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,307 Total Patients Enrolled
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
7 Previous Clinical Trials
556 Total Patients Enrolled

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05142241 — Phase 2
Cancer Research Study Groups: Treatment (talazoparib, temozolomide)
Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT05142241 — Phase 2
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142241 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the pioneering experiment in its field?

"Talazoparib has been studied for nearly two decades. The first clinical trial started in 2002, sponsored by Schering-Plough and involved 60 patients. Following the completion of Phase 1, Talazoparib was approved for use in phase 2 trials across 45 countries and 1280 cities; at present there are over 260 active studies being conducted with this drug."

Answered by AI

What medical conditions can be treated by Talazoparib?

"Aside from being used for nitrosourea treatment, talazoparib can also be taken to address conditions such as refractory advanced mycosis fungoides, advance directives and refractory neuroblastoma."

Answered by AI

Could you provide an overview of the prior research conducted pertaining to Talazoparib?

"Currently, Talazoparib is the subject of 261 active research studies with 27 trials in its late-stage. While a majority are situated within Seoul and Songpa, there are 7056 sites currently undertaking clinical tests for this drug."

Answered by AI

How many individuals are actively engaged in this clinical experiment?

"Correct. Online records from clinicaltrials.gov indicate that this investigation, which was initially posted on March 23rd 2022 is actively enrolling participants. A total of 34 volunteers are required at two distinct trial sites."

Answered by AI

How deleterious is Talazoparib to humans?

"Talazoparib's safety was determined to be a 2 due to the existing evidence from Phase 2 trials, which shows some support for its security but does not confirm any efficacy."

Answered by AI

Is enrollment currently available for this research endeavor?

"Affirmative. The information published on clinicaltrials.gov reveals that this medical study, which began recruiting participantson March 23rd 2022, is actively seeking enrollees. The trial requires 34 individuals to be recruited from 2 locations."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What site did they apply to?
National Cancer Institute Developmental Therapeutics Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~18 spots leftby Apr 2026