NCT01199718

Brief Summary

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

September 9, 2010

Last Update Submit

June 13, 2011

Conditions

Multiple Myeloma

Keywords

Multiple myelomaPlasmacytoma

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.

    One year (assessed at Cycle 1).

Secondary Outcomes (3)

  • Pharmacokinetic and pharmacodynamic assessments.

    One year - assessed throughout all cycles of participation

  • Assess for efficacy response

    One year (assessed after each cycle)

  • Establish the recommended Phase 2 dose

    One year

Study Arms (1)

CX-4945

EXPERIMENTAL

CX-4945 oral formulation

Drug: CX-4945

Interventions

CX-4945DRUG

CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.

CX-4945

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females at least 18 years of age
  • Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
  • Measureable disease.
  • Karnofsky Performance Status at least 60%
  • Adequate liver and renal function and hematology laboratory values
  • Female patients of child-bearing potential must have a negative pregnancy test.
  • Signed informed consent.

You may not qualify if:

  • Treatment with systemic cancer therapy within 21 days before screening.
  • Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
  • Grade 3 sensory neuropathy or motor neuropathy with pain
  • Concurrent severe or uncontrolled medical disease.
  • Active systemic fungal, bacterial, and/or viral infection.
  • Difficulty with swallowing, or an active malabsorption syndrome.
  • Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.
  • History of gastric or small bowel surgery.
  • Pregnant or nursing females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Kettering, Ohio, 45249, United States

RECRUITING

Oregon Health Science University

Portland, Oregon, 97239, United States

RECRUITING

Unknown Facility

Springfield, Oregon, 97477, United States

RECRUITING

Unknown Facility

Greenville, South Carolina, 29605, United States

RECRUITING

Unknown Facility

Norfolk, Virginia, 23502, United States

RECRUITING

Unknown Facility

Yakima, Washington, 98902, United States

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaPlasmacytoma

Interventions

silmitasertib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Study Director

    Cylene Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

US(6)