A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

NCT01240720 | Completed Phase 1

• 1 other identifier: PH-F16SIPI131-06/07
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent. The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.

Conditions

Cancer

Keywords

I131; F16; antibody; monoclonal; tumor targeting; radioimmunotherapy; lymphoma, breast and lung cancer; Patients with different cancer types

Outcome Measures

Primary Outcomes (2)

• Phase I: Maximum tolerated Dose

  Establishment of the maximum tolerated dose (MTD), a recommended dose (RD) for the phase II part, and the safety of dosimetric and therapeutic administration of escalating dosages of the human radiolabeled antibody 131I-F16SIP.

  4 weeks

• Phase II: Antitumour activity

  Investigation of the antitumour activity of 131I-F16SIP at the RD.

  14 months

Secondary Outcomes (5)

• Phase I: Study of the variation of radioactivity of 131I or 124I in whole blood, at several time intervals (Pharmacokinetics)

  2 days

• Phase II: Adverse Events as a Measure of Safety

  30 days/ administration

• Phase II: Overall Response Rate (ORR)

  6 and 12 months

• Phase II: Progression free survival (PFS)

  6 and 12 months

• Phase II: Survival rate

  6 and 12 months

Study Arms (1)

I131-F16SIP

EXPERIMENTAL

Phase I: Multicentre, open-label, two-step singlearm dose escalation study in sequential cohorts of patients with cancer. Phase II: Prospective, open-label, single-arm, multicentre study of 131I-F16SIP, given at the RD of 55.5 mCi/m2, as determined in phase I.

Drug: 131I-F16SIP Radioimmunotherapy (RIT)

Interventions

131I-F16SIP Radioimmunotherapy (RIT) DRUG

* Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy. * Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V).

I131-F16SIP

Eligibility Criteria

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

You may qualify if:

• Phase I:
• Patients with cancer, with progressive disease in pre-study period, refractory to conventional standard treatments.
• Solid Tumor: Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer or colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology.
• Lymphoproliferative Diseases: Histologically/cytologically confirmed diagnosis of lymphoproliferative disease. At least one measurable (minimum 2.0 cm) non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology.
• Phase II:
• ECOG performance status grade 0 or 1.
• Age ≥18.
• Adequate haematological, liver and renal function (haemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase≤ 2.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL.
• All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.
• Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
• If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
• Evidence of a personally signed and dated IEC-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
• Life expectancy of at least 3 months.
• Signed and dated informed consent.

You may not qualify if:

• Chemotherapy, radiation, hormonotherapy or immunotherapy or participation in any investigational drug study within 4 weeks of RIT treatment at the RD (6 weeks in case of prior nitroureas chemotherapy).
• Prior radiation dose \> 30% of bone marrow volume.
• Presence of cirrhosis or active hepatitis.
• Presence of serious cardiac (congestive heart failure, heart insufficiency \> grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.
• Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
• Recovery from major trauma including surgery within 4 weeks of administration of study treatment.
• Pregnancy or lactation or unwillingness to use adequate method of birth control.
• Active infection or incomplete wound healing.
• Known history of allergy to intravenously administered proteins / peptides / antibodies.
• Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.

Sponsors & Collaborators

• Philogen S.p.A.: lead
• Eudax S.r.l.: collaborator

Study Sites (6)

University Hospital Pisa

Pisa, Tuscany, 56126, Italy

Location

Policlinico S. Orsola-Malpighi- Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

ASUR Zona Territoriale 9, Medicina Nucleare Ospedale di Macerata

Macerata, Italy

Location

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)

Meldola, Italy

Location

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli

Napoli, Italy

Location

Arcispedale Santa Maria Nuova Di Reggio Emilia

Reggio Emilia, Italy

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maddalena Sansovini, Dr

  IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 15, 2010
• Study Start: September 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IT (6)