Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Recurrence

Leukemia

Leukemia, Plasma Cell

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Plasma Cell Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Filanesib

Antimitotic Agents

Patients receive filanesib IV over 1 hour on days 1, 2, 15, and 16 and carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 8 courses of therapy, patients may continue with dosing of carfilzomib on days 1, 2, 15, and 16 and filanesib as tolerated. If patient progresses on carfilzomib maintenance with administration on days 1, 2, 15, and 16 they may increase the intensity and add in days 8 and 9 dosing.

Carfilzomib

Laboratory Biomarker Analysis

Robert Orlowski

This phase I trial studies the side effects and best dose of filanesib when given together with carfilzomib in treating patients with multiple myeloma or plasma cell leukemia that has returned or does not respond to treatment. Drugs used in chemotherapy, such as filanesib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filanesib together with carfilzomib may be a better treatment for multiple myeloma or plasma cell leukemia.

PRIMARY OBJECTIVES:

I. To determine the safety and the maximum-tolerated dose (MTD) of filanesib (ARRY-520) when combined with carfilzomib.

SECONDARY OBJECTIVES:

I. To obtain preliminary estimates of the efficacy of ARRY-520 when combined with carfilzomib.

II. To explore potential markers for patient selection and obtain a preliminary assessment of the biological activity of ARRY-520 when combined with carfilzomib.

OUTLINE: This is a dose-escalation study.

Patients receive filanesib intravenously (IV) over 1 hour on days 1, 2, 15, and 16 and carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 8 courses of therapy, patients may continue with dosing of carfilzomib on days 1, 2, 15, and 16 and filanesib as tolerated. If patient progresses on carfilzomib maintenance with administration on days 1, 2, 15, and 16 they may increase the intensity and add in days 8 and 9 dosing.

After completion of study treatment, patients are followed up within 30 days and then periodically thereafter.

Filanesib and Carfilzomib in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

A Phase I Study of Arry-520 and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Pomalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 \& 16, + pomalidomide administered p.o. at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 \& 22

Patients will be treated with 28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 \& 16, + pomalidomide administered p.o. at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 \& 22. G-CSF prophylaxis is mandatory in all patients after Filanesib, starting from Day 3 and Day 17 (for a total of 7 days each). Treatment will be continued until progression or unacceptable toxicity.

Filanesib, pomalidomide and dexamethasone

Ocio Enrique, DR

Phase I/II, Multicenter, Open Label, Clinical Trial to evaluate safety and efficacy and determine the Maximum Tolerated Dose (MTD) of Filanesib in combination with pomalidomide and dexamethasone in relapsed/refractory (R/R) Multiple Myeloma (MM) patients

National, multicenter, open label single-arm, non-comparative study, that will evaluate the MTD and the efficacy of the Kinesin Spindle Protein (KSP) inhibitor Filanesib (ARRY-520) in combination with pomalidomide + dexamethasone in relapsed or refractory MM patients.

For this purpose, relapsed or refractory MM patients after at least two prior lines of therapy including bortezomib and lenalidomide, who are refractory or intolerant to lenalidomide and refractory to the last line of therapy will be treated with 28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 \& 16, + pomalidomide administered po at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 \& 22. G-CSF prophylaxis is mandatory in all patients after Filanesib, starting from Day 3 and Day 17 (for a total of 7 days each). Treatment will be continued until progression or unacceptable toxicity.

Initially, a Phase I will be conducted using a modified 3+3 dose-escalating algorithm. The first three patients will be enrolled in the first dose level (see Figure 1 for dose escalation levels). If no DLT occurs among them, the next cohort of three patients will continue at the next higher dose level. If a DLT occurs among the first three evaluable patients during the first cycle, three more patients will be enrolled at the same dose level.

If no more than one DLT is observed among the six evaluable patients in this expanded dose group during cycle 1, enrollment will continue at the next higher dose level following the same scheme.

If more than one DLT occurs among the three or six evaluable patients included in the 1st cohort, an alternative dose escalation will be started, with a reduction of the dose of pomalidomide (see Figure 1). Patients will be then treated following again the same 3+3 algorithm. If more than one DLT out of three or six patients occur at the first dose level of the alternative escalation, the study will be stopped.

MTD will be considered as the dose level in which ≤1 DLT are observed among 6 evaluable patients, therefore, at least six patients must be treated at a given dose before this dose is considered the MTD.

Once the MTD is determined in Phase I, additional patients will be treated at this dose in the Phase II portion of the trial in order to define the activity and further define the toxicity of the combination at the MTD.

Patient participation in the study will comprise several periods:

The pre-treatment period includes the screening visit. After providing the written Informed Consent form to participate in the study, patients will be evaluated for eligibility during a screening period of up to 21 days (Days -21 to -1).

During the treatment period, all patients will receive Filanesib in combination with pomalidomide and dexamethasone in 28-days-cycles until progression or unacceptable toxicity.

Patients receiving the combination will be evaluated for efficacy and toxicity after the completion of each cycle.

No intra-patient escalation will be performed, that is, patients included at a given dose level during the Phase I will remain at this dose level during all treatment unless a dose reduction is required for toxicity.

All patients that discontinue treatment for any other cause different to disease progression will be evaluated in the follow-up period every two months for 1 additional year, for disease status, survival and safety (including second primary malignancies). All patients that have progressed at the end of treatment will be followed for survival and safety only (including second primary malignancy), being phone contact acceptable.

Patients will be considered to be on-study from the signature of the Informed Consent to the end of the follow-up period. Patients will be considered to be on-treatment for the duration of their treatment and in the first 30 days following treatment discontinuation. Treatment discontinuation is defined as the day of the last study drug dose administration.

Patients will receive the study combination while it is considered to be in their best interest. Specifically, treatment will continue until one or more of the following events occur:

* Disease progression.
* Unacceptable toxicity.
* Patient refusal.
* Intercurrent serious illness.
* Protocol deviation with an effect on the risk/benefit ratio of the clinical trial.
* Treatment delay \> 4 weeks (except in case of clear clinical benefit, with the sponsors' approval).
* Study closure.

Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients

Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients

Efficacy of the Kinesin Spindle Protein (KSP) inhibitor Filanesib (ARRY-520) in combination with pomalidomide + dexamethasone in relapsed or refractory MM patients.

Array BioPharma

Celgene Corporation

PETHEMA Foundation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Filanesib and Carfilzomib in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia	NCT01372540	Plasma Cell Leu... Recurrent Plasm... Refractory Plas...	Carfilzomib Filanesib Laboratory Biom...	18 Years -	M.D. Anderson Cancer Center
Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients	NCT02384083	Multiple Myelom...	Filanesib, poma...	18 Years -	PETHEMA Foundation
Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients	NCT02384083	Multiple Myelom...	Filanesib, poma...	18 Years -	PETHEMA Foundation
Filanesib and Carfilzomib in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia	NCT01372540	Plasma Cell Leu... Recurrent Plasm... Refractory Plas...	Carfilzomib Filanesib Laboratory Biom...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for filanesib

Every month we try and update this database with for filanesib 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 filanesib

Every month we try and update this database with for filanesib 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 filanesib 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.