Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

NCT01632696 | Terminated Early Phase 1

• 1 other identifier: PPHM 1201
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Tumor Imaging of I-124 PGN65 in Solid Tumors

Conditions

Malignant Solid Tumor

Keywords

Antibodies, Monoclonal; Biologics; F(ab')2; Positron-emission tomography (PET); Phosphatidylserine (PS); Solid Tumors; Tumor Imaging

Outcome Measures

Primary Outcomes (3)

• To estimate the intensity and distribution in critical and non-critical organs.

  Day 1

• To estimate the intensity and distribution in critical and non-critical organs.

  Day 2

• To estimate the intensity and distribution in critical and non-critical organs.

  Day 3

Secondary Outcomes (2)

• The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.

  Day 1, Day 2 and Day 3

• Demonstrate the safety of tumor imaging in patients with solid cancers.

  Day 1, Day 2 and Day 3

Study Arms (1)

I-124 PGN650 for PET/CT

EXPERIMENTAL

Drug: I-124 PGN650 for PET/CT

Interventions

I-124 PGN650 for PET/CT DRUG

I-124 PGN650 for PET/CT Day 1, Day 2 and 3.

Also known as: I-124 PGN650

I-124 PGN650 for PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Male or female, ≥ 18 years of age.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (1)

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Study Officials

• Farrokh Dehsashti, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (1)