Phase I Clinical Trials

10 trials identified.

INCYTE 54828-101 Advanced Malignancies
Principal Investigator: Mettu, Niharika
Protocol Number: PRO00061567

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Breast; Other Digestive Organ; Other Urinary; Urinary Bladder

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Advanced cancers 
What is the Purpose of this Study?
We are doing this study to find out the dose of the study drug INCB054828 that is safe and tolerable in people with advanced cancer.
Who Can Participate in the Study?
Part 1: Adults with any advanced solid tumor malignancy.
Part 2: Adults with documented FGF/FGFR alteration.
Part 3: Adults (+/- FGF/FGFR alterations) and solid tumor malignancies for which gemcitabine + cisplatin, docetaxel, trastuzumab, and PD-1 treatment is relevant.

- Must provide archival tumor tissue or undergo a fresh tumor biopsy.
What is Involved?
This study will be divided into three parts.

Part 1 is looking for the maximum tolerated dose of the study drug.
Part 2 will look at the dose selected from Part 1 in squamous non-small lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma (MM), and myeloproliferative neoplasms (MPN).
Part 3 will look at the study drug in combination with gemcitabine and cisplatin, docetaxel, pembrolizumab, trastuzumab or INCMGA00012.

All patients will be required to:
- Provide multiple blood and urine samples during the study
- Come to the study center for a series of physical exams, tests and scans (Computerized tomography (CT) or Magnetic resonance imaging (MRI))
- Undergo an eye exam
Participating Institutions:
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Genentech GO30140- Solid Tumors
Principal Investigator: Strickler, John
Protocol Number: PRO00072845

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Esophagus

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Hepatocellular Carcinoma
What is the Purpose of this Study?
We are doing this study to learn what effects, good or bad, atezolizumab has on you and your cancer when combined with bevacizumab and to make sure it is safe.
Who Can Participate in the Study?
Adults who:
- Have advanced or metastatic and/or unresectable hepatocellular carcinoma
What is Involved?
If you choose to join this study, you will:
- Receive either atezolizumab or atezolizumab and bevacizumab every 3 weeks through a vein in your arm 
-- Continue to receive the study drug as long as your doctor thinks it is safe
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

A Multicenter, Open Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated with Cancer
Principal Investigator: Boortz-Marx, Richard
Protocol Number: PRO00082543

Age Group: Adult
Scope: National

Phase: I
Disease Site: Multiple Myeloma

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Uncontrolled pain due to advanced cancer or cancer that has spread (metastasized)
What is the Purpose of this Study?
We are doing this study to learn whether a study drug called resiniferatoxin (also called RTX) is safe and effective in treating severe pain. 
Who Can Participate in the Study?
Adult patients:
- With advanced cancer or metastasis that has not responded to standard therapy and causing uncontrolled pain from the chest down to the lower legs.
- With moderate-to-severe pain
- Who are not currently seeking or receiving potentially curative therapies for cancer (palliative therapy is acceptable).  

For more information about who can be in the study please contact the study team.
What is Involved?
If you choose to join this study, you will:

- Have 8 clinic visits, one of which will require you to stay for up to 10 hours

- Visit 1 will include a physical exam, ECG, blood and urine tests. 
-- You will be also be taught how to report your pain score on a diary (log).  

- Visit 2 you will receive the study drug and you will stay in the hospital for up to 8 hours and blood and urine samples will be collected.  
-- Blood and urine sample will be collected. 

- Visits 3-8: will include a physical exam, ECG, blood and urine sample and a review of your pain logs.  

You'll be in the study for about 3 and a half months.
Participating Institutions:
  • Duke University Health System
View this trial at ClinicalTrials.gov

Eisai H3B-6527-G000-101 for HCC or ICC
Principal Investigator: Morse, Michael
Protocol Number: PRO00085459

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Liver

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Advanced hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
What is the Purpose of this Study?
We are doing this study to find the maximum dose of the study drug that is safe for patients to take. We also want to learn if the study drug can make the size of your tumor smaller. 
Who Can Participate in the Study?
Adults who:
- Have advanced hepatocellular carcinoma or intrahepatic cholangiocarcinoma
- Have had treatment with sorafenib if you have HCC or have had cisplatin/oxaliplatin if you have ICC
What is Involved?
If you choose to join this study, you will:
- Take the study drug, called H3B-6527, by mouth every day in 21 day cycles
- Continue to take the study drug as long as the study doctors thinks it is safe
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AbbVie M16-438
Principal Investigator: Strickler, John
Protocol Number: PRO00086471

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Ill-Defined Sites

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colorectal cancer or Glioblastoma (brain tumor)
What is the Purpose of this Study?
We are doing this study to learn if the new drug, ABBV-321 is safe when given to patients with colorectal cancer or glioblastoma. 

We start with a Dose Escalation phase is to find the highest dose that can be safely tolerated by patients, which is called the Maximum Tolerated Dose (MTD). 

We then do an Expanded Safety phase to get a better understanding of the safety of the drug at the MTD in a larger number of people.
Who Can Participate in the Study?
Adults who are diagnosed with colorectal cancer or glioblastoma. 
What is Involved?
There are two phases to this study:

Phase 1 is where the study drug ABBV-321 will be given through a vein once every 28 days and will be given in higher doses until we can get the highest and safest dose.

Phase 2 is where patients will be watched for side effects (good or bad) of the study drug ABBV-321 (given through a vein) at the dose found in Phase 1.
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10061 Pembrolizumab + Recombinant Interleukin-12 in Solid Tumors
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00087751

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Ill-Defined Sites

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Solid tumor that is locally advanced or widespread (metastatic)
What is the Purpose of this Study?
We are doing this study to test the safety of the study drug called recombinant Interleukin-12 (IL-12) given before and after pembrolizumab. 
Who Can Participate in the Study?
Adult patients with a solid tumor that is locally advanced or widespread (metastatic)
What is Involved?
There are two parts to the study: Group 1 Dosing Finding and Group 2 Dose Continuation.  

If you join the study the group you are assigned to depends on when you enter the study. Your doctor will tell you to which group you are assigned.

Group 1- The first several study participants will receive the lowest dose of recombinant Interleukin-12. If the lowest dose does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for the next study participants until side effects occur that require the dose to be lowered. Then the dose finding part of study is closed to enrollment and the dose continuation study group (below) opens for enrollment. 

Group 2 - Participants will receive the dose of recombinant Interleukin-12 identified to be safest 
Participating Institutions:
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov

HALOZYME HALO -110-101 for Liver and Biliary Cancers
Principal Investigator: Morse, Michael
Protocol Number: PRO00089907

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Liver

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Liver and biliary cancers
What is the Purpose of this Study?
We are doing this study to find out if the two study drugs PEGPH20 and Atezolizumab given with the current standard of care medications Cisplatin and Gemcitabine are safe and to find out what dose will work in patients with liver or biliary cancers.
Who Can Participate in the Study?
Adults who:
-Have previously untreated, locally advanced or metastatic ICC, ECC, and gallbladder adenocarcinoma 
What is Involved?
 you choose to join this study, you will:
-Be randomized (like drawing numbers out of a hat) to get either:
-- The combination of PEGPH20, cisplatin and gemcitabine 
-- PEGPH20, atezolizumab, cisplatin and gemcitabine, 
-- The standard of care for your cancer, which is cisplatin and gemcitabine
- Have tests, exams, and procedures that are part of your standard care and for study purposes. 
-- Each clinic visit will last 4-5 hours
Participating Institutions:
  • Duke University Health System
View this trial at ClinicalTrials.gov

Adaptimmune: Cancers that have the Protein MAGE-A4
Principal Investigator: Clarke, Jeffrey
Protocol Number: PRO00100343

Age Group: Adult
Scope: National

Phase: I
Disease Site: Esophagus; Lung; Melanoma, skin; Other Digestive Organ; Other Urinary; Ovary; Soft Tissue

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Cancers that have the protein MAGE-A4
What is the Purpose of this Study?
We are doing this study to find out if MAGE A4c1032T is safe and to find the best dose of this drug.
Who Can Participate in the Study?
Adults who have one of the following cancers:.
- Urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal pelvis), 
- Melanoma, 
- Squamous cell carcinoma of the head and neck, 
- Ovarian cancer,
- NSCLC (squamous, adenosquamous, adenocarcinoma, or large cell),
- Esophageal (squamous and adenocarcinoma)
- Gastric cancer, 
- Synovial sarcoma 
- Myxoid/Round Cell Liposarcoma (MRCLS).

Cancer must be positive for MAGE-A4
What is Involved?
If you choose to join this study, you will:
- Have your blood filtered through a machine to remove your T cells (a type of immune cell in your blood)
- Have your T cells changed in a lab to attack your cancer cells
- Have four days of chemotherapy before you get the study drug, MAGE A4c1032T
- Be admitted to the hospital to get the study drug
- Be followed for safety for a minimum of three months after you get the study drug
Participating Institutions:
  • Duke Cancer Center Cary : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Primary Care : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Raleigh Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Regional Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Johnston Health (Smithfield) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10009 Pembro + Entinostat in Myelodysplastic Syndromes
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00100355

Age Group: Adult
Scope:

Phase: I
Disease Site: Other Hematopoietic

Contact: DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's

What is the Condition Being Studied?
Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that arose from prior MDS
What is the Purpose of this Study?
We are doing this study to test whether giving entinostat by mouth along with the other drug pembrolizumab by vein is a safe combination and whether it could help your MDS or AML. 
Who Can Participate in the Study?
Adults who have:
- Confirmed MDS diagnosis
or
- Acute myeloid leukemia (AML) that arose from prior MDS
What is Involved?
If you agree to be in the study you will: 

-  Be assigned to one of 2 groups (you will be told which group you are assigned)

Group 1 (Dose escalation) 
- Get the study drug entinostat with a fixed dose of pembrolizumab
-- The first 3 to 6 study patients will get entinostat on day 1 and day 8 of each cycle.  
-- The next 3 to 6 study patients will get entinostat only on day 1 of each cycle. 
-- If this dose does not cause serious side effects, this dose will be used in the next part of the study (Dose expansion group-see below)

Group 2 (Dose Expansion) 
- Will get entinostat given with pembrolizumab 

The study drugs are given as follows: 
- Entinostat by mouth either on day 1 alone, on day 1 and 8, or on days 1, 8, and 15 at the study center (depending at what point you join in the study) on a 21 day cycle 
- Pembrolizumab once every 21 days by vein at the study center
Participating Institutions:
  • Duke Cancer Center Cary : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Primary Care : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Raleigh Hospital : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Regional Hospital : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke University Health System : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Johnston Health (Smithfield) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Leukemia - Multiple Myeloma DCI Clinical Research Team, Lymphoma - Hodgkin's - Non-Hodgkin's DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10136 AZD1775 in Patients with CCNE1 Amplification
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00101068

Age Group: Adult
Scope:

Phase: II
Disease Site: Ill-Defined Sites

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Advanced cancer with a change in the gene called the CCNE1 (Cyclin E1) gene
What is the Purpose of this Study?
We are doing this study to learn if the study drug AZD1775 is safe and can help control the disease in patients with advanced cancer with changes in Cyclin E1 gene.
Who Can Participate in the Study?
Adults with advanced cancer with a change in the gene called the CCNE1 (Cyclin E1) gene who:
- Have not had radiation treatment within 7 days of starting the study drug
- Are able to swallow pills
- Have biopsy tissue available or will agree to study biopsies
What is Involved?
If you choose to join this study, you will: 
- Take the study drug AZD1775 by mouth once daily for five days during the first and second week of each 3-week cycle.
Participating Institutions:
  • Duke Cancer Center Cary : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Primary Care : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Raleigh Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Regional Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Johnston Health (Smithfield) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov