A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma

NCT03033316 | Terminated Phase 1 DMC

• 1 other identifier: 14-097
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Oncocort Dexamethasone sodium phosphate encapsulated in so-called 'long-circulating' PEGylated liposomes is in development with the prospect of providing enhanced and prolonged lesion uptake of dexamethasone and therefore increased therapeutic benefit over existing formulations of dexamethasone in Multiple Myeloma. The current trial is a first-in-man study with Oncocort monotherapy with the objective to assess safety, tolerability, efficacy and dose response after short-term treatment with repeated infusions.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Liposomal Dexamethasone; Targeted Drug Delivery

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Week 8

Secondary Outcomes (5)

• Response according to IMWG Criteria

  4 and 8 weeks after 1st dose

• Percentage change of myeloma-related measures

  up to 8 weeks after 1st dose

• Quality of life questionnaire

  up to 8 weeks after 1st dose

• Peak Plasma Concentration (Cmax)

  during 1st 4 weeks

• Area under the plasma concentration versus time curve (AUC)

  during 1st 4 weeks

Study Arms (1)

IV Liposomal Dexamethasone

EXPERIMENTAL

IV Liposomal Dexamethasone given 1 to 4 times in total over period of maximally 4 weeks

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

IV Liposomal Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously diagnosed symptomatic MM according to International Myeloma Working Group (IMWG) criteria 1.1. Previously treated with at least two therapy lines including at least one proteasome-inhibitor and at least one immunomodulatory drug 1.2. Relapse after or progressive disease under last therapy according to IMWG criteria.
• At least 18 years old
• Measurable disease (M-protein and/or free light chains) in serum and/or urine
• Willing and able to comply the study protocol visits and assessments
• Willing to use highly effective methods of birth control (see section 7.1.3)
• Written informed consent prior to study participation

You may not qualify if:

• Types of Multiple Myeloma previously shown to be irresponsive to dexamethasone monotherapy during the last 6 months
• Plasma cell leukemia
• Subject with positive hepatitis panel (including hepatitis B surface antigen \[HBsAg\], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody \[anti-HCV\]), and / or a positive HIV antibody screen
• Severe abnormal organ function function or laboratory results at the time of the Screening Visit: WBC \<3.0 g/L, ANC \<1.5 G/L, PLT \<50 G/L, Sodium \<135 mmol/L or \>150 mmol/L, potassium \<3.5 mmol/L or \>5.5 mmol/L, calcium \<2.0 mmol/L or \> 2.9mmol/L, phosphorus \<0.8 mmol/L, total bilirubin \>1.5x ULN, AP \>2.5x ULN, gammaGT \>3x ULN, ALT \>3x ULN, CK \>2.5x ULN, Creatinine \>2x ULN, fasting glucose \>250 mg/dL, albumin \<3 g/dL, cholesterol \> 300 mg/dL
• Treatment with oral or injectable (including intra-articular) corticosteroids (CS) within 4 weeks prior to Screening Visit. Inhaled and dermal corticosteroid formulations are allowed
• Subjects who have received a chemotherapeutic treatment cycle including dexamethasone within 4 weeks prior to the Screening Visit
• Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to intravenous medications, biologic therapy or IV radiocontrast agents
• Active infection requiring systemic treatment
• Planned major surgery during the study period or had undergone major surgery within 30 days prior to the Screening visit
• Pregnancy or breastfeeding
• Any clinically significant hepatic, renal, cardiac, pulmonary, gastrointestinal, metabolic or endocrine disturbances, other medical or psychiatric condition, or clinically relevant abnormal values on any investigation, in the opinion of the Investigator, that could make the subject unsuitable for the study, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study, including severe neuropathies or other painful conditions that might interfere with pain evaluation
• The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
• The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
• The subject is unwilling or unable to follow the procedures outlined in the protocol
• The subject is mentally or legally incapacitated

Sponsors & Collaborators

• Enceladus Pharmaceuticals BV: lead
• University Hospital, Aachen: collaborator
• Accelovance: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Stefan Wilop, MD

  RWTH University Clinic Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share