- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01632696
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
July 7, 2017 updated by: Peregrine Pharmaceuticals
Tumor Imaging of I-124 PGN65 in Solid Tumors
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors.
All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled.
All study subjects will receive a single intravenous (IV) dose of I-124 PGN650.
Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650.
Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint.
Tumor and whole body radioactivity distribution will be measured.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine, Siteman Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Signed informed consent form.
- Male or female, ≥ 18 years of age.
- Histologically or cytologically confirmed solid tumors at any stage with at least one lesion (primary, metastatic, or recurrent) ≥ 1.5 cm in diameter documented by CT. If the lesion is located in a lymph node, the shortest diameter of the lymph node must be ≥ 1.5 cm as defined by RECIST 1.1. (Note: See Exclusion Criteria #1.)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate baseline hematological and organ function, assessed by laboratory values prior to study treatment as follows: absolute neutrophil count (ANC) > 1.0 x 109/L; hemoglobin > 7 g/dL; serum creatinine < 2 x institutional upper limit of normal (IULN); aspartate transaminase (AST) < 2.5 x IULN; alanine transaminase (ALT) < 2.5 x IULN; (if liver metastases are present, ALT and AST < 5 x IULN); total bilirubin < 1.5 x IULN.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence), for the duration of study participation (i.e., from dosing day 1 until study day 8). Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient must be willing and able to undergo the imaging studies outlined in the protocol.
Exclusion Criteria
- Only measureable disease (primary or metastatic) is located in or near the thyroid gland, liver, kidney, or urinary bladder.
- Medical conditions such as ischemic heart or lung disease that may be considered an unacceptable risk.
- Females who are lactating or pregnant.
- Persistent acute toxicities from prior anti-cancer therapy.
- History of hypersensitivity to iodine.
- Known bladder outlet obstruction.
- Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.
- Patients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I-124 PGN650 for PET/CT
|
I-124 PGN650 for PET/CT Day 1, Day 2 and 3.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To estimate the intensity and distribution in critical and non-critical organs.
Time Frame: Day 1
|
Day 1
|
To estimate the intensity and distribution in critical and non-critical organs.
Time Frame: Day 2
|
Day 2
|
To estimate the intensity and distribution in critical and non-critical organs.
Time Frame: Day 3
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.
Time Frame: Day 1, Day 2 and Day 3
|
Day 1, Day 2 and Day 3
|
Demonstrate the safety of tumor imaging in patients with solid cancers.
Time Frame: Day 1, Day 2 and Day 3
|
Day 1, Day 2 and Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Farrokh Dehsashti, M.D., Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
June 12, 2012
First Submitted That Met QC Criteria
June 28, 2012
First Posted (Estimate)
July 3, 2012
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
July 7, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPHM 1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Solid Tumor
-
Daiichi Sankyo Co., Ltd.RecruitingAdvanced Solid Tumor | Malignant Solid TumorUnited States, Japan
-
Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.RecruitingNeoplasms | Solid Tumor | Malignant TumorChina
-
Bristol-Myers SquibbCompletedMalignant Solid TumorUnited States, France, Italy, Australia, Canada, Germany, Netherlands
-
Nektar TherapeuticsCompletedMalignant Solid TumorUnited States, Belgium
-
Medical University of ViennaUnknown
-
AstraZenecaMerck Sharp & Dohme LLC; Iqvia Pty LtdCompletedMalignant Solid TumorBelgium
-
Shanghai Acebright Pharmaceuticals Co., Ltd.UnknownMalignant Advanced Solid TumorChina
-
Eli Lilly and CompanyCompletedMalignant Solid TumorUnited States
-
Aadi Bioscience, Inc.RecruitingMalignant Solid Neoplasm | Neoplasms | Cancer | Neoplasm Metastasis | Solid Tumor | Metastatic Cancer | Metastasis | Advanced Solid Tumor | Metastatic Solid Tumor | Advanced Cancer | Tumor | Malignant Neoplasm | Malignant Tumor | Tumors | Cancer Metastatic | Tumor, Solid | Malignant Solid Tumor | TSC | TSC1 | TSC2 | Metastatic NeoplasmKorea, Republic of, United States, Puerto Rico
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
Clinical Trials on I-124 PGN650 for PET/CT
-
Memorial Sloan Kettering Cancer CenterCompletedThyroid Cancer, Papillary | Thyroid Cancer, Follicular | Thyroid Carcinoma | Thyroid Cancer | Thyroid Cancer (Follicular Cell) | BRAF V600E Mutation PositiveUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingThyroid Carcinoma | Metastatic Thyroid CarcinomaUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedGlioblastoma | Brain MetastasesUnited States
-
Asan Medical CenterTerminatedPheochromocytoma | ParagangliomaKorea, Republic of
-
Jena University HospitalGE HealthcareUnknownThyroid Diseases | Thyroid Nodule | Thyroid GoitreGermany
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid... and other conditionsUnited States
-
Stanford UniversityTerminatedBreast Cancer | Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Cancer Metastatic Breast CancerUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedNasopharyngeal Cancer | Gastric Cancer | Hodgkin Lymphoma | Non Hodgkin Lymphoma | Kaposi's SarcomaUnited States
-
Peking Union Medical College HospitalRecruiting
-
Dallas VA Medical CenterTerminatedSolid Tumors | Cancer RecurrenceUnited States