Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Digestive System Diseases

Exanthema

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Coagulants

Vitamins

Irinotecan

Antibodies

Antibodies, Monoclonal

Cetuximab

Fluorouracil

Folic Acid

Immunoglobulins

Mitogens

Vitamin B Complex

Vitamin K

Vitamin K 1

Antineoplastic Agents, Immunological

Folinic Acid

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Folate

Vitamin B9

1. Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR).
2. FOLFIRI regimen

Administration Schedule:

Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks)

* Irinotecan 180 mg/m² iv , 90 min on day 1
* Folic acid (racemic) 400 mg/m², 120 min on day 1
* 5-FU 400 mg/m² bolus on day 1
* 5-FU 2400 mg/m² iv over 46 h on day 1 to 2

FOLFIRI + Cetuximab

Carl Christoph Schimanski, PD Dr. med.

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

Further Objectives:

1. Development of acneiforme follicular exanthema \>= grade 2
2. Duration until development of acneiforme follicular exanthema \>= grade 2
3. Development of paronychia
4. Development skin fissure (hand and foot)
5. Objective remission according RECIST 1.1
6. Rate of secondary resections of liver metastasis with a curative approach
7. Assessment of safety and tolerability
8. Overall survival
9. Progression free survival

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

* disease progression
* complete response
* development of status of operability
* an uncontrollable exanthema grade 3 or 4 or
* intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment

FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Progression-free survival rate at 12 months

Objective response rate over the entire treatment period

Duration until development of acneiforme follicular exanthema \>= grade 2 during treatment-phase

Development of paronychia during treatment-phase

Development of skin fissure (hand and foot) during treatment-phase

Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase

Assessment of safety and tolerability during treatment phase

Development of acneiforme follicular exanthema \>= grade2 during treatment phase

Dr. Carl Schimanski

Principal Investigator

Rare Diseases

Glioblastoma

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

Temozolomide

Trace Elements

Antineoplastic Agents, Alkylating

Alkylating Agents

Antifibrinolytic Agents

Hemostatics

Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given intramuscular (IM) to all subjects prior to the beginning of each week of therapy.

After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.

Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.

BPM31510

Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg Intramuscularly prior to the beginning of each week of BPM31510 therapy.

Vitamin K1

After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.

Temozolomide (TMZ)

After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.

Radiation

Vijay Modur, MD, PhD

Arianne Lyng

Chirag Patil, MD,MS

Seema Nagpal, MD

Rebecca M Brown, MD,PhD

Adam Cohen, MD

This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.

The study will start with a dose-confirmation phase to establish safety of BPM31510 in combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the starting dose of BPM31510 at 110 mg/kg/week (wk), with 1 potential dose de-escalation to 66 mg/kg/wk in the event a DLT is experienced at the 110 mg/kg dose. Toxicity at this dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). Subjects will be monitored for DLTs associated with combination therapy for 30 days (d) (± 5 d) after the end of RT (DLT assessment period). Subjects will continue to be monitored for late radiation-related DLTs during follow up, every 8 wk (± 2 wk) during the first 12 months (mo), and then every 12 wk (± 2 wk) for a total of 5 years (y). Safety oversight will be provided by the independent Data and Safety Monitoring Committee (DSMC). The DSMC will review and confirm all DLT data, make recommendations for dose modifications, if necessary, and continue to monitor safety throughout the study. The efficacy phase of the study will begin after the recommended Phase 2 dose (RP2D) has been confirmed.

A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

Progression free survival will be determined by measuring the proportion of subjects who have met RANO criteria for complete response, partial response , or stable disease at 6 mo following initiation of BPM31510.

Overall survival as determined by measuring from start date of BPM31510 to the date of death or date of last follow-up (for subjects who have not died).

A DLT is defined as an event possibly related to BPM31510 and clearly not due to an underlying disease or extraneous causes. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema	NCT01315990	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)	NCT04752813	Glioblastoma Glioblastoma Mu...	BPM31510 Vitamin K1 Temozolomide (T... Radiation	18 Years -	Berg, LLC
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema	NCT01315990	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz

Spots Global Cancer Trial Database for vitamin k1

Every month we try and update this database with for vitamin k1 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 vitamin k1

Every month we try and update this database with for vitamin k1 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 vitamin k1 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.