Trials Sponsors Conditions Drugs Pricing

Brief Summary

RATIONALE: The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and molecular alterations that ultimately lead to intestinal dysfunction/failure. This intestinal dysfunction manifests as several pathological processes, such as inability to absorb nutrients, intestinal inflammation, immune system dysregulation, and disequilibrium of normal intestinal microbiota leading to increased risk of infection due to bacterial translocation and septicaemia. Gastrointestinal (GI) mucositis is a well-known, frequent and debilitating side effect of most anticancer regimens with a very high incidence in hemato-oncology. The most common symptoms are nausea, vomiting, weight loss, abdominal cramps and pain, diarrhea, and electrolyte imbalance. Patients may also experience ulceration/bleeding and injury of the lining of the entire gastrointestinal tract from the esophagus to the colon. Currently no therapy is available for the prevention or treatment of GI intestinal injury. Treatment of related symptoms is limited to supportive measures to decrease diarrhea and to preventive antibiotic therapy. The GLP-2 analogue, FE 203799, has a favorable pharmacology profile for clinical development in the intended therapeutic indication of myeloablative chemotherapy-induced GI damage. The data collected from animal studies has shown that FE 203799 stimulates the proliferation of the intestinal epithelium and protects the GI mucosa from chemotherapy-induced injury. Hence, the primary pharmacologic activity of FE 203799 would promote a healthy GI microenvironment, thus preventing intestinal dysfunction and related complications. PURPOSE: Prevention by FE 203799 of chemotherapy-induced intestinal damage and related complications in patients with lymphoma receiving Melphalan based (BEAM) myeloablative conditioning regimen followed by hematopoietic stem cell transplantation.

Conditions

Lymphoma, Non-Hodgkin's, Adult Lymphoma, Hodgkin's, Adult

Keywords

gastrointestinal mucositismyeloablative chemotherapyautologous transplantation

Outcome Measures

Primary Outcomes (1)

Incidence of treatment-emergent adverse events
Adverse events as assessed by CTCAE v4.03
Day -8 to Day 100

Secondary Outcomes (19)

Maximum observed plasma concentration (Cmax) of FE 203799
Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) time curve from 0-168 hours of FE 203799
Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) from time zero to infinity of FE 203799
Day -8 to Day 13
Terminal elimination half-life (T1/2) of FE 203799
Day -8 to Day 13
Apparent total body clearance (CL) of the drug from plasma of FE 203799
Day -8 to Day 13
+14 more secondary outcomes

Study Arms (3)

Cohort A: 5 mg (FE 203799/Placebo)

EXPERIMENTAL

Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

Drug: FE 203799

Cohort B: 10 mg (FE 203799/Placebo)

EXPERIMENTAL

Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

Drug: FE 203799

Cohort C: 25 mg (FE 203799/Placebo)

EXPERIMENTAL

Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

Interventions

FE 203799Drug

GLP-2 analogue, once weekly, subcutaneous administration

Cohort A: 5 mg (FE 203799/Placebo)Cohort B: 10 mg (FE 203799/Placebo)Cohort C: 25 mg (FE 203799/Placebo)

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult male and non-pregnant or lactating female patients diagnosed with Hodgkin's lymphoma (HL) or non- Hodgkin's lymphoma (NHL; T- or B-cell variants) based on histological or cytological evidence.
Patients are eligible to receive myeloablative chemotherapy as per center eligibility criteria, followed by AHSCT.

Sponsors & Collaborators

VectivBio AG
Industrycollaborator
GlyPharma Therapeutics
Industrylead

MeSH Terms

Conditions

LymphomaHodgkin DiseaseMucositis

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

Tomasz Masior
VectivBio AG
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double-blind
Purpose: SUPPORTIVE CARE
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

January 31, 2018

Study Start

September 1, 2018

Estimated (date passed)

You may not qualify if:

Patient is unable or unwilling to give informed consent.
Patients who are unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
Patients with known hypersensitivity to FE 203799, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions to any drugs.
Patients with an active infection or with a fever ≥38.5oC within 3 days of the first scheduled day of dosing.
Patients who had an autologous stem cell transplant within 24 months.
Patients who had an available cryopreserved autologous graft with a CD34+ cell count of \< 2 x 106/kg.
Patients undergoing AHSCT for conditions other than lymphoma.
Presence of a malignancy other than the one for which the transplant is being performed (except for baso-cellular skin carcinoma).
Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 30 days prior to the first scheduled day of dosing with FE 203799.
Patients with cardiovascular congestive heart failure, unstable angina pectoris, cardiac arrhythmias requiring a pacemaker; myocardial infarction within the past six months; stroke within the past 6 months; or uncontrolled hypertension.
Patients with mean QTcF values of \>450 msec (in males) or \>470 msec (in females) following ECGs conducted in triplicate 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes, including patients who are already on medication known to cause prolonged QT intervals on ECG.
Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 220 msec, QRS \< 60 msec, QRS \>119 msec) on the screening ECG or other clinically significant ECG abnormalities.
Patients with history or presence of GI tract cancer, polyps, ulcerative colitis, Crohn's disease, coeliac disease, tropical sprue, etc.
Presence of active pancreatic disease.
Presence of active liver disease (i.e. cirrhosis; bilirubin \> ULN; transaminases \> 1.5 x ULN; alkaline phosphatase \> 2.5 x ULN).
+6 more criteria

Study Stopped

Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (3)

Cohort A: 5 mg (FE 203799/Placebo)

Cohort B: 10 mg (FE 203799/Placebo)

Cohort C: 25 mg (FE 203799/Placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Study Stopped

Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (3)

Cohort A: 5 mg (FE 203799/Placebo)

Cohort B: 10 mg (FE 203799/Placebo)

Cohort C: 25 mg (FE 203799/Placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record