Your session is about to expire
← Back to Search
PARP Inhibitor
Talazoparib + Temozolomide for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Jonathan Goldman, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is studying talazoparib and temozolomide to treat extensive-stage small cell lung cancer.
Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer that has returned after initial chemotherapy. Participants must be able to swallow pills, not have used PARP inhibitors or temozolomide before, and agree to contraception. They should not have other cancers within the last 2 years (with some exceptions) or conditions affecting study participation.Check my eligibility
What is being tested?
The effectiveness of talazoparib combined with low-dose temozolomide is being tested in participants with relapsed or refractory extensive-stage small cell lung cancer. Talazoparib may prevent tumor cells from repairing DNA, while temozolomide aims to stop their growth.See study design
What are the potential side effects?
Potential side effects include blood disorders like anemia and neutropenia, fatigue, nausea, vomiting, hair loss (alopecia), constipation or diarrhea. There might also be risks related to DNA repair inhibition such as secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My lung cancer is confirmed to be extensive-stage small cell type.
Select...
I can provide a tissue sample for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1
Secondary outcome measures
Duration of response (CR or PR) per RECIST 1.1
Overall survival
PFS assessed by RECIST 1.1
+3 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 (temozolomide, talazoparib)Experimental Treatment2 Interventions
Participants receive temozolomide PO on days 1-5 and talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,649 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,983 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,684 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to donate sperm or eggs during and up to 105/45 days after my treatment.I am capable of understanding and agreeing to the trial's terms.I have recovered from previous treatment side effects, except for hair loss or acceptable lab results.I haven't had another cancer, except certain types, in the last 2 years.My blood clotting time is normal or managed if I'm on blood thinners.My cancer worsened after initial strong chemotherapy.I haven't taken any experimental drugs in the last 14 days.I have had radiation therapy to the chest or brain before.My cancer returned within 6 months or didn't respond to initial platinum-based treatment.I can take pills, have no allergies to the study drugs, and can follow the study rules.My kidney function is good, with a filtration rate of at least 30 mL/min.I am not pregnant and agree to use effective birth control during and 45 days after the study.My blood clotting time is normal or managed with medication.I have been treated with a PARP inhibitor or temozolomide before.I will use a condom during the study and for 105 days after it ends.I am not breastfeeding and will not for 45 days after the last treatment.Your absolute neutrophil count is at least 1,500 per microliter of blood.My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.I have been diagnosed with myelodysplastic syndrome.I have not had major surgery in the last 14 days.I am fully active or can carry out light work.I have previously received immunotherapy or targeted therapies.You must have at least 100,000 platelets per microliter of blood.I haven't used cancer drugs in the last 14 days.My lung cancer is confirmed to be extensive-stage small cell type.I have undergone more than one round of chemotherapy.I have a stomach or intestine condition that affects how my body absorbs food.I am not using and do not plan to use certain medications that could affect my treatment.You have a tumor that can be measured according to specific guidelines.I can provide a tissue sample for testing.My liver function tests are within the required range.Your bilirubin levels in the blood should not be higher than a certain limit.I have not had radiation therapy in the last 14 days, except for a one-time treatment for symptom relief.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (temozolomide, talazoparib)
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.
Is this clinical experiment currently accessible to participants?
"As indicated on clinicaltrials.gov, this particular medical trial has ceased recruiting participants. It was initially posted on October 31st 2018 and the latest update is dated February 7th 2022. Despite this, there are still 4110 other studies actively looking for volunteers to participate in their investigations."
Answered by AI
Has the FDA endorsed Talazoparib as a viable therapeutic option?
"According to our internal evaluation, talazoparib's safety was rank a 2 since this is a Phase 2 trial. This implies that there is only limited evidence of its security but no data demonstrating its efficiency."
Answered by AI
How widely dispersed are the research centers conducting this experiment across the state?
"Patients can enroll in this research trial at locations such as the Cancer Center of Kansas in Wichita, Kansas, St. Joseph Heritage Healthcare in Fullerton, Indiana or Ft. Wayne Medical Oncology and Hematology Inc., located in Fort Wayne, Florida among other sites."
Answered by AI
What is the current enrollment size for this research project?
"At the present moment, this trial is not recruiting any new patients. It was posted on October 31st 2018 and last edited on February 7th 2022. However, there are currently 3849 trials enrolling participants with carcinoma and 261 studies involving Talazoparib that have open enrolment."
Answered by AI
What indications are commonly treated with Talazoparib?
"Talazoparib is a viable treatment option for patients with nitrosourea resistant, advanced mycosis fungoides and those who have already completed advance directives."
Answered by AI
To what extent have there been other experiments involving Talazoparib?
"Currently, 261 clinical trials are running for Talazoparib. Of those studies, 27 have advanced to Phase 3. Despite the majority of these research projects being based in Seoul and Songpa, there is a total of 7056 locations conducting them worldwide."
Answered by AI
Has a similar endeavor been undertaken before this one?
"Talazoparib has had a long history with clinical trials, beginning in 2002. Initially sponsored by Schering-Plough, the Phase 1 trial included 60 patients and was successful enough to prompt further research into this medication. Nowadays there are 261 active studies utilizing Talazoparib occurring in 1280 cities across 45 nations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger