Malignant Solid TumorEarly Phase 1NCT01632696
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
A Early Phase 1 study testing I-124 PGN650 for PET/CT in people with Malignant Solid Tumor, run by Peregrine Pharmaceuticals at 1 site in United States.
Trial summary
Tumor Imaging of I-124 PGN65 in Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- I-124 PGN650 for PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Tumor Imaging of I-124 PGN65 in Solid Tumors
Read the 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.
- Conditions
- Malignant Solid Tumor
- Being tested
- I-124 PGN650 for PET/CT
- Keywords
- Antibodies, Monoclonal, Biologics, F(ab')2, Positron-emission tomography (PET), Phosphatidylserine (PS), Solid Tumors, Tumor Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-124 PGN650 for PET/CTDrug
Also called I-124 PGN650
I-124 PGN650 for PET/CT Day 1, Day 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| I-124 PGN650 for PET/CT | Experimental | Not described Receives: Drug: I-124 PGN650 for PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the intensity and distribution in critical and non-critical organs.
Measured: Day 1
To estimate the intensity and distribution in critical and non-critical organs.
Measured: Day 2
To estimate the intensity and distribution in critical and non-critical organs.
Measured: Day 3
Secondary outcomes (2)
The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.
Measured: Day 1, Day 2 and Day 3
Demonstrate the safety of tumor imaging in patients with solid cancers.
Measured: Day 1, Day 2 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farrokh Dehsashti, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632696
- Sponsor's protocol ID
- PPHM 1201
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2012
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01632696
- Acronym / sponsor ID
- PPHM 1201
- Conditions
- Malignant Solid Tumor
- Keywords
- Antibodies, Monoclonal, Biologics, F(ab')2, Positron-emission tomography (PET), Phosphatidylserine (PS), Solid Tumors, Tumor Imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tumor Imaging of I-124 PGN65 in Solid Tumors
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-124 PGN650 for PET/CT | Experimental | Drug: I-124 PGN650 for PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-124 PGN650 for PET/CTAlso: I-124 PGN650I-124 PGN650 for PET/CT Day 1, Day 2 and 3. | Drug | I-124 PGN650 for PET/CT |
Primary outcome
To estimate the intensity and distribution in critical and non-critical organs.
Time frame: Day 1
To estimate the intensity and distribution in critical and non-critical organs.
Time frame: Day 2
To estimate the intensity and distribution in critical and non-critical organs.
Time frame: Day 3
2 secondary outcomes
The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.
Time frame: 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
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farrokh Dehsashti, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing I-124 PGN650 for PET/CT in people with Malignant Solid Tumor, run by Peregrine Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the intensity and distribution in critical and non-critical organs. (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.