Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Taxane

Alkylating Agents

Antimitotic Agents

Tubulin Modulators

BIIB022 in Combination with Paclitaxel and Carboplatin

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

BIIB022 With Paclitaxel and Carboplatin

The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer

Biogen

Therese Senta-McMillian, Clinical Team Manager

Administration of \[I-124\]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions.

A pre-targeting dose of CPD-1061 may be given prior to injection of \[I-124\]-CPD-1028.

A single intravenous dose of \[I-124\]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed.

[I-124]-CPD-1028 Injection

\[Optional\] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of \[I-124\]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data.

CPD-1061

Eric Burak, PhD

The purpose of the study is to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in cancer patients with solid tumours.

Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.

A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours

A Phase 1a, Multi-centre, Open-label, Non-randomized Study to Assess the Safety, Biodistribution and Tumour Uptake of [I-124]-CPD-1028 Injection

The safety of \[I-124\]-CPD-1028 Injection will be assessed for up to 30 days post injection by measuring the occurrence of adverse events and changes from baseline in physical examination, clinical laboratory parameters, electrocardiogram recordings, and vital signs (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation).

Biodistribution data will be assessed by quantitative analysis of imaging scans taken 2-3 days and 5-7 days post injection by (1) measuring tumour uptake and background tissue levels in selected regions of interest on whole body images and (2) determining if suitable quantitative imaging metrics can be identified.

Blood and plasma clearance of \[I-124\]-CPD-1028 and levels of free \[I-124\]-iodide will be assessed by analysis of blood and plasma samples taken up to 18 days post-injection.

\[I-124\]-CPD-1028 PET/CT images taken up to 18 days post-injection will be compared to immunohistochemistry staining scores of IGF-1R on previously obtained tumour samples.

\[I-124\]-CPD-1028 PET/CT images taken up to 18 days post-injection will be visually (qualitatively) compared to previously obtained CT and/or MRI images.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours	NCT02134340	Cancer	[I-124]-CPD-102... CPD-1061	18 Years -	Centre for Probe Development and Commercialization
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours	NCT02134340	Cancer	[I-124]-CPD-102... CPD-1061	18 Years -	Centre for Probe Development and Commercialization

Spots Global Cancer Trial Database for igf1r

Every month we try and update this database with for igf1r cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for igf1r

Every month we try and update this database with for igf1r cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for igf1r cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.