NCT01063907 · REGISTRY CONDITION SEARCH

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2024-04-25

The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).

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outcome · POSTED

Phase 1: PK Absorption Tmax hr Day 11

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outcome · POSTED

Phase 1: PK Exposure Cmax ng/mL Day 11

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outcome · POSTED

Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11

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outcome · POSTED

Phase 1: PK Elimination t½ hr Day 11

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Accepts Healthy Volunteers: No Inclusion Criteria: 1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed. 2. Signed either an IRB or IEC approved informed consent 3. ECOG performance status of ≤ 2 4. Life expectancy of at least 3 months 5. M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells \> 10%, and evidence of end organ damage 6. Adequate hematologic status, liver and renal function 7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study. Exclusion Criteria: 1. No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug 2. Any other severe, acute or chronic illness 3. No other prior or concurrent malignancy 4. No immunosuppressant therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Cohort 1: KW 2478 130 mg/m\^2 and Bortezomib 1.0 mg/m\^2
intervention Names
Drug: KW-2478
Drug: Bortezomib
label
Phase 1: Cohort 1
type
EXPERIMENTAL
description
Cohort 2: KW 2478 130 mg/m\^2 and Bortezomib 1.3 mg/m\^2
intervention Names
Drug: KW-2478
Drug: Bortezomib
label
Phase 1: Cohort 2
type
EXPERIMENTAL
description
Cohort 3: KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2
intervention Names
Drug: KW-2478
Drug: Bortezomib
label
Phase 1: Cohort 3
type
EXPERIMENTAL
description
Cohort 4: KW 2478 175 mg/m\^2 and Bortezomib 1.3 mg/m\^2
intervention Names
Drug: KW-2478
Drug: Bortezomib
label
Phase 1: Cohort 4
type
EXPERIMENTAL
description
KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2
intervention Names
Drug: KW-2478
Drug: Bortezomib
label
Phase 2
type
EXPERIMENTAL

interventions

arm Group Labels
Phase 1: Cohort 1
Phase 1: Cohort 2
Phase 1: Cohort 3
Phase 1: Cohort 4
Phase 2
description
Administered Days 1, 4, 8 and 11 of a 21 day cycle
name
KW-2478
other Names
HSP90 Inhibitor
type
DRUG
arm Group Labels
Phase 1: Cohort 1
Phase 1: Cohort 2
Phase 1: Cohort 3
Phase 1: Cohort 4
Phase 2
description
Administered on Days 1, 4, 8 and 11 of a 21 day cycle
name
Bortezomib
other Names
Velcade
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 95
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
measure
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
time Frame
21 day cycle, up to 52 weeks

secondary Outcomes

description
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
measure
Phase 1: PK Absorption Tmax hr Day 11
time Frame
PK collected Day 11 of 21-day cycle
description
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
measure
Phase 1: PK Exposure Cmax ng/mL Day 11
time Frame
PK collected Day 11 of 21-day cycle
description
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
measure
Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11
time Frame
PK collected Day 11 of 21-day cycle
description
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
measure
Phase 1: PK Elimination t½ hr Day 11
time Frame
PK collected Day 11 of 21-day cycle

Full study description

brief Summary: The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
detailed Description: This is a multicenter, open label, dose escalation, Phase I / II study in subjects with relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up to 101 subjects treated in the study. Study centers in the USA and the UK will participate in Phase I and II. Centers in the Philippines will be participating in Phase II only. The planned enrollment period is 22 months and the planned study duration is 28 months.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice