Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/2/2018 |
Start Date: | February 7, 2017 |
End Date: | December 2024 |
A Phase II Study of Talazoparib (BMN 673) in Patients With Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
This phase II trial studies how well talazoparib works in treating patients with homologous
recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has
come back after previous treatment. Talazoparib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth.
recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has
come back after previous treatment. Talazoparib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and
partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients.
SECONDARY OBJECTIVES:
I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival
(OS) associated with therapy in HRRD MDVN-positive patients.
II. To evaluate ORR, IA-PFS, and OS in HRRD Foundation Medicine, Inc. (FMI)-positive
patients.
III. To evaluate ORR in HRRD MDVN-negative/HRRD FMI-positive patients. IV. To evaluate the
frequency and severity of toxicities associated with talazoparib (BMN 673) in HRRD
FMI-positive patients.
TERTIARY OBJECTIVES:
I. To assess if the homologous recombination deficiency (HRD) score is associated with
clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib
(BMN 673).
II. To assess if the level of PARP protein expression determined by immunohistochemistry is
associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated
with talazoparib (BMN 673).
III. To characterize pharmacokinetic properties of talazoparib (BMN 673).
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) on days 1-21. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and at the end of year 3.
I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and
partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients.
SECONDARY OBJECTIVES:
I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival
(OS) associated with therapy in HRRD MDVN-positive patients.
II. To evaluate ORR, IA-PFS, and OS in HRRD Foundation Medicine, Inc. (FMI)-positive
patients.
III. To evaluate ORR in HRRD MDVN-negative/HRRD FMI-positive patients. IV. To evaluate the
frequency and severity of toxicities associated with talazoparib (BMN 673) in HRRD
FMI-positive patients.
TERTIARY OBJECTIVES:
I. To assess if the homologous recombination deficiency (HRD) score is associated with
clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib
(BMN 673).
II. To assess if the level of PARP protein expression determined by immunohistochemistry is
associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated
with talazoparib (BMN 673).
III. To characterize pharmacokinetic properties of talazoparib (BMN 673).
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) on days 1-21. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and at the end of year 3.
Inclusion Criteria:
- Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON
ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master
Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
- Patients must be assigned to S1400G; S1400G biomarker eligibility defined as
homologous recombination repair deficiency (HRRD) positive is as follows
- Biomarker-positive group
- HRRD by FMI
- Homologous recombination repair deficiency by Foundation Medicine Inc.,
criteria
- Alteration type
- Truncating mutation, frameshift deletions, indels missense and nonsense
mutations predicted to have functional consequence in any of the specified
genes
- Eligible alteration
- Mutation in any one of the following critical HRR pathway genes: ATM, ATR,
BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF,
FANCM, NBN (NBS1), PALB2, RAD51, RAD51B (RAD51L1), RAD54L, RPA1
- Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g.,
veliparib, olaparib, rucaparib, niraparib, talazoparib [BMN 673]) as its primary
pharmacology
- Patients must have achieved stable disease, a partial response, or a complete response
at their first disease assessment after initiating first-line platinum-based
chemotherapy; patients determined to have progressed (in the opinion of the treating
physician) at their first disease assessment are not eligible
- Patients may not have any impairment of gastrointestinal function or gastrointestinal
disease that may significantly alter the absorption of talazoparib (BMN 673) (e.g.,
ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome,
small bowel resection, or active peptic ulcer disease); patients must not have active
small or large intestine inflammation such as Crohn's disease or ulcerative colitis
(within 12 months of sub-study registration)
- Patients must be able to take oral medications; patients must be able to swallow
capsules whole without crushing or altering them in any way
- Patients must not be taking, nor plan to take while on protocol treatment strong
P-glycoprotein (P-gp) inhibitors, P-gp inducers, or breast cancer resistance protein
(BCRP) inhibitors; the language ?P-gp or BCRP inhibitors or inducers? is reworded to
?strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors? for consistency with the
investigator brochure
- Patients must agree to have blood specimens submitted for pharmacokinetic analysis
We found this trial at
1152
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Principal Investigator: Harish G. Ahuja
Phone: 877-405-6866
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Antioch, California 94531
Principal Investigator: Jennifer M. Suga
Phone: 510-891-3400
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921 North Oak Park Boulevard
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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364 White Oak St
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
(336) 625-5151
![Randolph Hospital](/wp-content/uploads/logos/randolph-hospital.png)
Principal Investigator: Vinay K. Gudena
Phone: 336-832-0821
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 800-506-2550
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 828-213-4150
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Asheville, North Carolina 28803
Principal Investigator: Raymond Thertulien
Phone: 828-213-4150
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Ashland, Kentucky 41101
Principal Investigator: David K. Goebel
Phone: 888-823-5923
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1625 Maple Lane
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
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Athens, Georgia 30607
Principal Investigator: Sharad A. Ghamande
Phone: 706-353-5006
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550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
![Emory University Hospital Midtown](/wp-content/uploads/logos/emory-university-hospital-midtown.png)
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000
![Northside Hospital](/wp-content/uploads/logos/northside-hospital.jpg)
Principal Investigator: Sreekanth C. Reddy
Phone: 404-303-3355
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, Georgia 30322
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
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Atlanta, Georgia 30342
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
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Auburn, California 95602
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Auburn, California 95603
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Auburn, Washington 98001
Principal Investigator: John A. Keech
Phone: 907-458-5380
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Augusta, Georgia 30912
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
![University of Colorado Hospital](/wp-content/uploads/logos/university-of-colorado-hospital-site.jpg)
Principal Investigator: Jose M. Pacheco
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200
![Rush - Copley Medical Center](/wp-content/uploads/logos/rush---copley-medical-center.png)
Principal Investigator: Yujie Zhao
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Aventura, Florida 33180
Principal Investigator: Michael A. Schwartz
Phone: 305-674-2625
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 907-458-5380
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
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Bakersfield, California 93301
Principal Investigator: David R. Gandara
Phone: 916-734-3089
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Baldwin Park, California 91706
Principal Investigator: Han A. Koh
Phone: 626-564-3455
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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Baltimore, Maryland 21218
Principal Investigator: Deepa S. Subramaniam
Phone: 202-444-2223
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Baltimore, Maryland 21229
Principal Investigator: Carole B. Miller
Phone: 410-368-2910
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Baltimore, Maryland 21237
Principal Investigator: Deepa S. Subramaniam
Phone: 202-444-2223
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
![University of Maryland Greenebaum Cancer Center](/wp-content/uploads/logos/university-of-maryland-greenebaum-cancer-center.jpg)
Principal Investigator: Katherine A. Scilla
Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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6701 N Charles St
Baltimore, Maryland 21204
Baltimore, Maryland 21204
(443) 849-2000
![Greater Baltimore Medical Center](/wp-content/uploads/logos/greater-baltimore-medical-center.png)
Principal Investigator: Mei Tang
Phone: 443-849-3706
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
![Sinai Hospital of Baltimore](/wp-content/uploads/logos/sinai-hospital-of-baltimore.jpg)
Principal Investigator: Roberto F. Martinez
Phone: 410-601-6120
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, Maryland 21244
Principal Investigator: Leon C. Hwang
Phone: 301-548-5743
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
![Johns Hopkins University-Sidney Kimmel Cancer Center](/wp-content/uploads/logos/johns-hopkins-university-sidney-kimmel-cancer-center.png)
Principal Investigator: Julie R. Brahmer
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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489 State St
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7000
![Eastern Maine Medical Center](/wp-content/uploads/logos/eastern-maine-medical-center.png)
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
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Baton Rouge, Louisiana 70805
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 504-988-6121
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 504-988-6121
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Baton Rouge, Louisiana 70809
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: Marc R. Matrana
Phone: 504-842-3708
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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