Clinical trial NCT03377556
Conditions: ATM Gene Mutation ATR Gene Mutation BARD1 Gene Mutation BRCA1 Gene Mutation BRCA2 Gene Mutation BRIP1 Gene Mutation CHEK1 Gene Mutation CHEK2 Gene Mutation FANCA Gene Mutation FANCC Gene Mutation FANCD2 Gene Mutation FANCF Gene Mutation FANCM Gene Mutation NBN Gene Mutation PALB2 Gene Mutation RAD51 Gene Mutation RAD51B Gene Mutation RAD54L Gene Mutation Recurrent Squamous Cell Lung Carcinoma RPA1 Gene Mutation Stage IV Squamous Cell Lung Carcinoma AJCC v7
Sponsor: SWOG Cancer Research Network
Start date: 2017-03-03; Completion date: 2021-04-16
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Patients receive talazoparib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pharmacological Study intervention 3: Talazoparib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Prot_SAP_000.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400G, “A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous 
Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer)” 
 
 
NCT Number: 03377556 
 
 
Version Date: 7/19/19 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400G [NCT 03377556].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400G is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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ICF_001.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400G, “A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous 
Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer)” 
 
 
NCT Number: 03377556 
 
 
Version Date: 7/19/19 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400G [NCT 03377556].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400G is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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