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
Arizona
City: Scottsdale RECRUITING
Facility: Mayo Clinic (Arizona)
Contact Info:
No contact info provided
California
City: Los Angeles RECRUITING
Facility: USC Norris Comprehensive Cancer Center
Contact Info:
No contact info provided
City: Santa Barbara RECRUITING
Facility: Sansum Clinic
Contact Info:
No contact info provided
City: Santa Rosa RECRUITING
Facility: Providence Medical Foundation
Contact Info:
No contact info provided
Colorado
City: Denver RECRUITING
Facility: Rocky Mountain Cancer Center
Contact Info:
No contact info provided
City: Denver RECRUITING
Facility: Sarah Cannon Research Institute at HealthONE
Contact Info:
No contact info provided
Florida
City: Fort Myers RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
No contact info provided
City: Jacksonville RECRUITING
Facility: Mayo Clinic (Florida)
Contact Info:
No contact info provided
City: Jacksonville RECRUITING
Facility: Cancer Specialist of North Florida
Contact Info:
No contact info provided
City: Jacksonville RECRUITING
Facility: Cancer Specialists of North Florida
Contact Info:
No contact info provided
City: Sarasota RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
No contact info provided
City: West Palm Beach RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
No contact info provided
Illinois
City: Hinsdale RECRUITING
Facility: Hope and Healing Cancer Services
Contact Info:
No contact info provided
Indiana
City: Indianapolis RECRUITING
Facility: Community Health Network
Contact Info:
No contact info provided
Louisiana
City: Baton Rouge RECRUITING
Facility: Our Lady of the Lake
Contact Info:
No contact info provided
Maryland
City: Columbia RECRUITING
Facility: Maryland Oncology Hematology - Primary
Contact Info:
No contact info provided
Minnesota
City: Maple Grove RECRUITING
Facility: Minnesota Oncology Hematology
Contact Info:
No contact info provided
City: Rochester RECRUITING
Facility: Mayo Clinic (Minnesota)
Contact Info:
No contact info provided
Missouri
City: St Louis RECRUITING
Facility: Washington University
Contact Info:
No contact info provided
New York
City: East Syracuse RECRUITING
Facility: Hematology Oncology Associates of Central New York
Contact Info:
No contact info provided
Ohio
City: Cincinnati RECRUITING
Facility: Oncology Hematology Care Primary
Contact Info:
No contact info provided
City: Maumee RECRUITING
Facility: Taylor Cancer Research Center
Contact Info:
No contact info provided
Oklahoma
City: Oklahoma City RECRUITING
Facility: Stephenson Cancer Center
Contact Info:
No contact info provided
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania / Abramson Cancer Center
Contact Info:
No contact info provided
City: Philadelphia RECRUITING
Facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Contact Info:
No contact info provided
Tennessee
City: Chattanooga RECRUITING
Facility: Tennessee Oncology, PLLC
Contact Info:
No contact info provided
City: Nashville RECRUITING
Facility: SCRI Oncology Partners
Contact Info:
No contact info provided
Texas
City: Austin RECRUITING
Facility: Texas Oncology - Central/South Texas
Contact Info:
No contact info provided
City: Dallas RECRUITING
Facility: Mary Crowley Cancer Research
Contact Info:
No contact info provided
City: Dallas RECRUITING
Facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
Contact Info:
No contact info provided
City: Flower Mound RECRUITING
Facility: Texas Oncology - Northeast Texas
Contact Info:
No contact info provided
City: San Antonio RECRUITING
Facility: Texas Oncology - San Antonio
Contact Info:
No contact info provided
Utah
City: Salt Lake City RECRUITING
Facility: Utah Cancer Specialists
Contact Info:
No contact info provided
Virginia
City: Fairfax RECRUITING
Facility: Virginia Cancer Specialists
Contact Info:
No contact info provided
Other Countries
Country: France
City: Bordeau RECRUITING
Facility: Institut Bergonie
Contact Info:
No contact info provided
Country: France
State: Cedex
City: Villejuif RECRUITING
Facility: Institut Gustave Roussy
Contact Info:
No contact info provided
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:
No contact info provided
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: START Madrid Fundacion Jimenez Diaz
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: Madrid RECRUITING
Facility: START Madrid (Hospital San Chinarro)
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: Pamplona RECRUITING
Facility: Hospital Universitario De Navarra
Contact Info:
No contact info provided
Country: Spain
City: Seville RECRUITING
Facility: Hospital Virgen Macarena
Contact Info:
No contact info provided
Country: Spain
City: Seville 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:
No contact info provided
Country: Spain
State: Alicante
City: Elche RECRUITING
Facility: Hospital General Universitario de Elche
Contact Info:
No contact info provided
Country: Spain
State: Barcelona
City: Sabadell RECRUITING
Facility: H. Parc Tauli
Contact Info:
No contact info provided
Country: Spain
State: Catalonia
City: Barcelona RECRUITING
Facility: Next Oncology Barcelona, IOB
Contact Info:
No contact info provided
Country: Spain
State: Catalonia
City: Lleida RECRUITING
Facility: Hospital Arnau de Vilanova
Contact Info:
No contact info provided
Country: Spain
State: Madrid
City: Madrid RECRUITING
Facility: Hospital Universitario La Paz
Contact Info:
No contact info provided
Country: Spain
State: Madrid
City: Pozuelo de Alarcón RECRUITING
Facility: Next - Hospital Quironsalud Madrid
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:
No contact info provided
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: Sarah Cannon Research Institute UK
Contact Info:
No contact info provided
Country: United Kingdom
State: London
City: London RECRUITING
Facility: Guy's and St Thomas' NHS Foundation Trust
Contact Info:
No contact info provided
Study Contact Information:
For additional information, please contact:
Sarah Cannon Development Innovations by phone: 844-710-6157 or by email.