## Protocol Section
### Identification Module
**NCT ID:** NCT06433128

**Brief Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections

**Official Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options

#### Organization Study ID Info
**ID:** EAP to Fosmanogepix
#### Organization
**Class:** INDUSTRY
**Full Name:** Basilea Pharmaceutica
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** AVAILABLE

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Basilea Pharmaceutica

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

### Conditions Module

**Conditions:**

- Invasive Fungal Infections

**Keywords:**

- Fungal infection

- Candida

- Anti-fungal

- Yeast

- Mold

- Rare mold

### Design Module

#### Expanded Access Types

**Individual:** True

**Study Type:** EXPANDED_ACCESS

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration

**Name:** Fosmanogepix solution for infusion

**Type:** DRUG

#### Intervention 2

**Description:** Fosmanogepix 400 mg tablets for oral administration

**Name:** Fosmanogepix 400 mg tablets

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fosmanogepixeap@wepclinical.com

**Name:** WEP-Clinical Pharmaceutical Services Provider

**Role:** CONTACT

**Contact 2:**

**Email:** marc.engelhardt@basilea.com

**Name:** Marc Engelhardt

**Phone:** +41 79 701 0551

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M12136

- Name: Mycoses

- Relevance: HIGH

- As Found: Fungal Infections

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M1099

- Name: Invasive Fungal Infections

- Relevance: HIGH

- As Found: Invasive Fungal Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000009181

- Term: Mycoses

- ID: D000072742

- Term: Invasive Fungal Infections

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
