Treatment with an ATR Inhibitor for Advanced or Metastatic Solid Tumors
Study Contact Information:
For additional information, please contact:
Sarah Cannon Development Innovations by phone: 844-710-6157 or by email.
About the Study
This study will look at how well a new oral known as an ATR inhibitor works on advanced or solid tumors with mutations in genes linked to damage repair. The study will look at response to treatment with the drug ART0380 either alone or in combination with the chemotherapy agent, gemcitabine.
Type of Study
This is an , study.
- All participants will receive the study drug ART0380 either alone or in combination with gemcitabine.
- All participants will know which medication they are receiving.
- The study will have different groups of participants. Participants will be assigned to a group based on type of cancer, tumor testing and/or genetic testing.
- the dose escalation groups will establish the ideal dose of ART0380.
- the dose expansion groups will include additional patient populations.
Participant groups:
- Group A1 - People with advanced or cancer that is not responsive to standard therapies, or for which no standard therapies exist.
- Group A2 - People with advanced or cancer for whom gemcitabine is appropriate treatment.
- Group B1 - People with advanced or cancer whose tumor shows a loss of the protein.
- Group B2 - People diagnosed with advanced, platinum-resistant ovarian cancer.
This Study is Open To:
People may be eligible if they:
- Have not received a previous treatment targeting the ATR/CHK1 pathway (this includes other ATR inhibitors, CHK1 inhibitors and WEE1 inhibitors).
- For participants with an inherited or somatic mutation, or a tumor that is positive and for which there is an approved , they should have received treatment before participating in this study.
- Have at least one tissue sample that can be followed by imaging at time of study enrollment and during future evaluations.
- Have tumor tissue samples that can be tested for loss of protein.
Additional inclusion criteria for participants in Group A1:
- Advanced or cancer that is not responsive to standard therapies, or for which no standard therapies exist
Additional inclusion criteria for participants in dose escalation (Part A2):
- Advanced or cancer for which gemcitabine is appropriate treatment.
Additional inclusion criteria for participants in dose expansion (Part B1):
- Advanced or cancer in which tumor testing shows a loss of protein.
Additional inclusion criteria for participants in dose expansion (Part B2):
- Advanced platinum-resistant ovarian, or primary peritoneal cancer that is not responsive to curative therapy.
- No more than one prior treatment in the platinum-resistant setting. Must have previously received bevacuzimab and chemotherapy.
- Have not received prior treatment with gemcitabine unless administered in combination with a platinum, and no disease progression after 12 months.
This Study is NOT Open To:
People with the following are not eligible for the study:
- Have recent HIV/AIDs-related infections, hepatitis B or hepatitis C, tuberculosis, an existing additional malignancy that is not in remission.
- Lung disease or pneumonitis.
- Moderate or severe heart disease.
- Brain metastases, spinal cord compression, or leptomeningeal disease (cancer cells that have migrated to the fluid around the brain and spinal cord) requiring treatment at the same time as this study.
What the Study Involves
All participants in this study will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
Group A1
- Participants will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
Group A2
- Participants will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
- Participants will also receive gemcitabine on Days 1 and 8 of a 21 day cycle.
Group B1
- Participants will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
Group B2
- Participants will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
- Participants will also receive gemcitabine on Days 1 and 8 of a 21 day cycle.
All study participants will be followed for up to 24 months.
Study Contact Information:
For additional information, please contact:
Sarah Cannon Development Innovations by phone: 844-710-6157 or by email.
Locations:
Alabama
City: Birmingham RECRUITING
Facility: University of Alabama at Birmingham
Contact Info:
No contact info provided
Arkansas
City: Little Rock RECRUITING
Facility: University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Contact Info:
No contact info provided
Colorado
City: Denver RECRUITING
Facility: Rocky Mountain Cancer Center
Contact Info:
Manojkumar Bupathi
City: Denver RECRUITING
Facility: Sarah Cannon Research Institute at HealthONE
Contact Info:
Gerald Falchook, MD
Florida
City: Fort Myers RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
Fadi Kayali, MD
City: Jacksonville RECRUITING
Facility: Cancer Specialists of North Florida
Contact Info:
Gaurav.Trikha@CSNF.us
904-825-4500
Gaurav Trikha, MD
City: Sarasota RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
Manish Patel, MD
City: West Palm Beach RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
Barry Scott Berman, MD
Indiana
City: Indianapolis RECRUITING
Facility: Community Health Network
Contact Info:
Bert O'Neil
Minnesota
City: Maple Grove RECRUITING
Facility: Minnesota Oncology Hematology
Contact Info:
Sandeep.Jain@usoncology.com
763-712-2100
Sandeep Jain, MBBS
New York
City: New York RECRUITING
Facility: Hematology Oncology Associated of Central New York
Contact Info:
Steven Duffy
Oklahoma
City: Oklahoma City RECRUITING
Facility: Stephenson Cancer Center
Contact Info:
Kathleen Moore, MD
Pennsylvania
City: Philadelphia RECRUITING
Facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Contact Info:
Babar Bashir, MD
Tennessee
City: Chattanooga RECRUITING
Facility: Tennessee Oncology, PLLC
Contact Info:
Edward Riker Arrowsmith, MD
City: Nashville RECRUITING
Facility: SCRI Oncology Partners
Contact Info:
Melissa Johnson, MD
Texas
City: Austin RECRUITING
Facility: Texas Oncology - Central/South Texas
Contact Info:
Marco.araneda@usoncology.com
956-425-8845
City: Dallas RECRUITING
Facility: Mary Crowley Cancer Research
Contact Info:
Minal Barve, MD
City: Dallas RECRUITING
Facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
Contact Info:
Scott Paulson
Utah
City: Salt Lake City RECRUITING
Facility: Utah Cancer Specialists
Contact Info:
Stephan Kendall
Virginia
City: Fairfax RECRUITING
Facility: Virginia Cancer Specialists
Contact Info:
No contact info provided
Other Countries
Country: France
State: Cedex
City: Villejuif RECRUITING
Facility: Institut Gustave Roussy
Contact Info:
Country: Spain
City: A Coruña RECRUITING
Facility: Hospital Teresa Herrera (CHUAC)
Contact Info:
No contact info provided
Country: Spain
City: Badalona RECRUITING
Facility: Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Vall d'Hebron Institute of Oncology (VIHO)
Contact Info:
Elena Elez
Country: Spain
City: Barcelona RECRUITING
Facility: Hospital Clinic de Barcelona
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: ICO Hospitalet
Contact Info:
No contact info provided
Country: Spain
City: Córdoba RECRUITING
Facility: Hospital Universitario Reina Sofia de Córdoba
Contact Info:
No contact info provided
Country: Spain
City: Girona RECRUITING
Facility: Hospital Universitari Doctor Josep Trueta- ICO de Girona
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital General Universitario Gregorio Marañón
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: MD Anderson Cancer Center (Madrid
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Clinico San Carlos
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario 12 de Octubre
Contact Info:
No contact info provided
Country: Spain
City: Malaga RECRUITING
Facility: Hospital Universitario Virgen de la Victoria
Contact Info:
No contact info provided
Country: Spain
City: Málaga RECRUITING
Facility: Hospital Universitario Virgen de la Victoria
Contact Info:
No contact info provided
Country: Spain
City: Sevilla RECRUITING
Facility: Hospital Virgen del Rocío
Contact Info:
No contact info provided
Country: Spain
City: Valencia RECRUITING
Facility: Incliva Biomedical Research Institute, University of Valencia
Contact Info:
No contact info provided
Country: Spain
City: Zaragoza RECRUITING
Facility: Hospital Universitario Miguel Servet
Contact Info:
Sara Perez
Country: Spain
State: Barcelona
City: Sabadell RECRUITING
Facility: H. Parc Tauli
Contact Info:
No contact info provided
Country: Spain
State: Murcia
City: El Palmar RECRUITING
Facility: Hospital Clínico Universitario Virgen de la Arrixaca
Contact Info:
No contact info provided
Country: Spain
State: Planta -2
City: Madrid RECRUITING
Facility: Clínica Universidad de Navarra
Contact Info:
Jorge Bartolome
Country: United Kingdom
City: Glasgow RECRUITING
Facility: Beatson West of Scotland Cancer Centre
Contact Info:
No contact info provided
Country: United Kingdom
City: London RECRUITING
Facility: Guy's and St Thomas' NHS Foundation Trust
Contact Info:
Country: United Kingdom
City: London RECRUITING
Facility: Sarah Cannon Research Institute UK
Contact Info:
Elisa Fontana
Study Contact Information:
For additional information, please contact:
Sarah Cannon Development Innovations by phone: 844-710-6157 or by email.