Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

All Drugs and Chemicals

Pharmaceutical Solutions

Iron

Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min).

Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.

Ferrotran® (Ferumoxtran-10)

Jürgen Feuerstein, Dr.

Volker Meyer, Dr.

This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.

Potential patients for this study will be recruited by up to 10 centres specialised in prostate cancer. Study sites will be interdisciplinary, consisting of a uro-oncology sub-site, and a radiology sub-site with high-quality MRI, surgery and pathology. Study visits will be typically conducted at the recruiting sub-site, or as institutionally appropriate. Treatment visits for patients will be performed in the collaborating sub-site. Patients will be invited for study participation by the investigators in the context of specialised clinics. Interested patients will be provided with an information sheet and will undergo a detailed informed consent procedure prior to any study procedures. Recruitment will be continued until a sufficient number of patients have undergone Ferrotran® imaging and histopathological evaluation.

To compensate for an expected drop-out rate of 15% to 20%, recruitment will only be stopped as soon as at least 69 evaluable positive (patients positive) and at least 104 evaluable negative (patients negative) patients are available for analysis.

Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).

True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.

ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.

b.e.imaging GmbH

Radboud University Medical Center

Saving Patients' Lives Medical B.V.

Antineoplastic Agents

Docetaxel

Tubulin Modulators

Antimitotic Agents

Day 1 of the Run-in a low dose of \[89Zr -Df-CriPec® docetaxel (corresponding to 0.1- 2 mg docetaxel). On Cycle 1 Day 1, the patients will receive unlabelled CriPec® docetaxel of a variable dose up to 60mg/m2 followed \< 2 h by a second low dose of \[89Zr\]-Df-CriPec® docetaxel. On day 1 of each subsequent cycle, patients will only receive unlabelled CriPec® docetaxel . The dose will be the same as was given on Cycle 1 Day 1. For the following patients the dose of unlabelled CriPec® docetaxel combined with the low dose of \[89Zr\]-Df- CriPec® docetaxel will be variable but never exceed the highest dose of unlabelled CriPec® docetaxel that was determined to be safe in the phase I NAPOLY trial (CT-CL01).

Cripec Docetaxel

A clinical phase I, open-label PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel.

After patient inclusion an fludeoxyglucose-18 (\[18F\]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of \[89Zr\]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 \[89Zr\] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of \[89Zr\]-Df-CriPec® docetaxel and maximally 3 \[89Zr\]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.

Phase I, open-label, single centre immune-PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel

PET Study With [89Zr]-Df-CriPec® Docetaxel

A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel

Visual detection (absent/present) of tumor uptake

Measured by SUVpeak values of visual positive lesions

Based on 89Zr PK activity concentration (Bq/ml) and biodistribution \[89Zr\]-Df-CriPec® docetaxel scans

Assessment of 89Zr PK (Bq/ml) and total docetaxel (ng/ml)

Measured by defining volumes of interest (VOI) of various organs on PET scan and calculating %ID/kg

Cristal Therapeutics

Amsterdam UMC, location VUmc

Principal Investigator

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Disease Progression

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antibodies

Doxorubicin

Liposomal doxorubicin

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

Mitogens

Panitumumab

EGFR(V)-EDV-Dox administered via 20 minute intravenous infusion once a week for seven weeks (1 Cycle). Subjects will receive one of two dose levels: 5 x 10\^9 or 8 x 10\^9. All subjects will undergo an adapted dose escalation regime in the first cycle of treatment. For subsequent cycles all doses will be administered at full strength (5x10\^9 or 8x10\^9 EGFR(V)-EDV-Dox). Subjects may receive further cycles of treatment if the tumor remains stable or is responding, and/or they are deriving clinical benefit from the therapy and are tolerating treatment.

EGFR(V)-EDV-Dox using EnGeneIC EDV™ technology is a bacterially derived minicell which packages a toxic payload, Doxorubicin, into a 400 nm particle which targets specific cancer cells using bispecific antibodies (BsAb). BsAb-targeted, payload-packaged EDV nanocells only exit the leaky blood vessels associated with tumors and enter into the tumor microenvironment. The BsAb binds to the tumor cell-surface receptor, where the EDV is taken up, broken down within the cancer cell and releases the Doxorubicin. The residual EDVs that do not make it into the tumor microenvironment, are engulfed by cells of the immune system and since the EDVs are derived from bacteria, they carry potent immuno-stimulating components which appear to bypass the immuno-suppression caused by the tumor.

EGFR(V)-EDV-Dox

Kelly Szajna, RN BSN

Whitney Webb, RN MSN CNRN

Tamika Wong, MPH

John A Boockvar, MD

Jennifer MacDiarmid, Ph.D

Himanshu Brahmbhatt, Ph. D

Gary L Gallia, M.D., Ph.D

Stuart A Grossman, M.D.

The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).

This is an open-label, Phase 1, dose exploration and preliminary immunogenicity study of single agent EGFR(V)-EDV-Dox in subjects with recurrent glioblastoma (GBM). Eligible subjects enrolled in the study will receive EGFR(V)-EDV-Dox administered weekly for 7 weeks via IV 20 minute infusion, followed by radiological evaluation at week 8 (1 Cycle). Subjects may continue to receive subsequent cycles of EGFR(V)-EDV-Dox unless the subject becomes intolerant to investigational product (IP), withdraw consent or the individual is no longer receiving clinical benefit (factors taken in to consideration will be disease progression radiologically or clinically, and clinical benefits to quality of life). Tumour assessment will be repeated after each 7 week cycle (week 8).

The study will take place in two parts, Part 1 (Dose Exploration) and Part 2 (Dose Expansion).

Part 1 - Dose Exploration will assess the safety and tolerability of multiple doses of drug at two dose levels (5 x 10\^9 and 8 x 10\^9) and will enroll prior to Part 2. Three subjects will be recruited per dose level. Enrollment will begin with the 5 x 10\^9 dose level, and the decision to enroll to the 8 x 10\^9 dose level will follow a comprehensive safety evaluation and a standard 3 + 3 dose escalation study design.

Part 2 - Dose Expansion will be conducted pending safety results of Part 1 to provide guidance regarding the recommended phase 2 dose (RP2D). Subjects will be treated and assessed as outlined in Part 1 above. If 0 out of 3 subjects, or 1 out of 6 subjects, experience dose limiting toxicities (DLTs) at the 5 x 10\^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. Similarly, if 0 out of 3 subjects, or 1 out of 6 subjects, experience DLTs at the 8 x 10\^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. If both dose levels are tolerated, a total of 10 subjects per dose level will be enrolled.

A safety follow-up visit must be performed 30 (+5) days after the last dose of drug for all subjects.All subjects who discontinue investigational product and who have not withdrawn full consent to participate in the study will continue in the long term follow-up phase. Long term follow-up will continue approximately every 1 month for 12 months, from the 30 (+5) day follow-up visit, then approximately every 2-3 months for the extent of subject survival.

A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of EGFR (Vectibix® Sequence)-Targeted EnGeneIC Dream Vectors Containing Doxorubicin (EGFR(V)-EDV-Dox) in Subjects With Recurrent Glioblastoma Multiforme (GBM)

Recording of adverse Events (AE's) and clinically significant changes in vital signs, physical and neurological examinations, cardiac tests, radiological imaging inc. CT scan (Day 27/28) and clinical laboratory tests.

Disease response will be measured by Magnetic Resonance Imaging (MRI) using Response Assessment in Neuro-Oncology (RANO).

Review of safety data for dose limiting toxicity (DLT) evaluable subjects.

Johns Hopkins University

Engeneic Pty Limited

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

2 IV injections (100 mg/Kg/injection) at day 4 and day 8 + Strereotactic Radiation from day 8 to day 15 as per standard practice.

AGuIX

This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.

AGuIX® (Activation and Guidance of Irradiation by X-ray, NH TherAguix) are Gadolinium chelated polysiloxane based nanoparticles with Magnetic Resonance contrast properties, able to accumulate in the tumor through the enhanced permeability and retention effect and sufficiently small (sub-5 nm diameter) to allow for renal clearance.

AGuIX® nanomedicine can be used as:

* Positive contrast agent for Magnetic Resonance Imaging (MRI). It displays higher efficacy than commercial contrast agents and so it can be used to delineate precisely the tumors.
* A booster of Radiotherapy during the radiotherapy protocol, after the localization of the tumor.

This is permitted by the high radiosensitizing potential of AGuIX® that allows a local increase of efficacy of X-ray damages. French and international groups have demonstrated the radiosensitizer effect of AGuIX® to improve the efficacy of radiotherapy.

Thanks to a difference in porosity between the vascular networks, AGuIX® penetrates and resides in tumor tissues, but not in healthy tissues.

This study is a paucicentric, single arm Phase II trial conducted according to a single stage Fleming-A'Hern design and aiming to evaluate the efficacy of AGuIX® during FSRT of brain metastasis.

Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases

A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.

The primary endpoint is the rate of local control defined as the proportion of patients with a complete response, a partial response or a stable disease. Response of Brain lesion will be evaluated using the RECIST classifications with partial response (PR, \> 30% decrease in longest diameter), stable disease (SD \<30% decrease and \<20% increase in longest diameter), progressive disease (PD \> 20% increase in longest diameter) and Complete response (CR) (complete disappearance of the brain lesion).

Distant Brain failure is defined as the presence of new brain metastases or leptomeningeal enhancement outside the irradiated volume.

The event of interest will be the local progression on any irradiated lesion.

The Tumor target volume agreement is the comparison between both the MRI images with AGuIX® and Gd-chelates. It is defined as the correlation between the irradiation volume calculated based on the MRI before nanoparticles injection and the volume calculated after nanoparticles injection.

Brain lesion 3-D volume variation will be analysed using volumetric T1 post-gadolinium MRI.

The assessment of safety will be based mainly on the frequency of adverse events based on the common toxicity criteria (CTCAE-V5.0) grade.

The FACT-Br consists of a general version (FACT-G) and a brain subscale (BRCS). The FACT-G consist of 27 questions with 4 domains assessing physical well-being (score range: 0-28), social/family well-being (score range: 0-28), emotional well-being (score range: 0-24) and functional well-being (score range: 0-28). The BRCs is a 23-item questionnaire related to neurological concerns that provides an additional set of disease-specific questions pertaining to brain neoplasms (score range: 0-92). The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Positive change scores indicate improved quality of life.

The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and the maximum score is 30 with higher MMSE scores indicating better cognition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients	NCT04261777	Prostate Cancer Metastasis Prostatectomy	Ferrotran® (Fer...	18 Years -	Saving Patients' Lives Medical B.V.
PET Study With [89Zr]-Df-CriPec® Docetaxel	NCT03712423	Solid Tumor	Cripec Docetaxe...	18 Years -	Amsterdam UMC, location VUmc
A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)	NCT02766699	Glioblastoma Astrocytoma, Gr...	EGFR(V)-EDV-Dox	18 Years -	Engeneic Pty Limited
Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases	NCT04094077	Brain Metastase...	AGuIX	18 Years -	Centre Leon Berard
A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)	NCT02766699	Glioblastoma Astrocytoma, Gr...	EGFR(V)-EDV-Dox	18 Years -	Engeneic Pty Limited

Spots Global Cancer Trial Database for nanoparticles