NCT00959959

Brief Summary

The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

8 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

August 14, 2009

Last Update Submit

September 2, 2020

Conditions

Prostate Cancer

Keywords

CRPCHRPCTOK-001ARMORARMOR1ESLGaleterone

Outcome Measures

Primary Outcomes (1)

  • Phase 1: Incidence of adverse events

    Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)

    3 months

Secondary Outcomes (1)

  • Efficacy Measures

    3 months

Study Arms (8)

650 mg TOK-001

EXPERIMENTAL
Drug: TOK-001

1300 mg TOK-001

EXPERIMENTAL
Drug: TOK-001

1950 mg TOK-001

EXPERIMENTAL
Drug: TOK-001

975 mg TOK-001

EXPERIMENTAL
Drug: TOK-001

975 mg TOK-001, supplement

EXPERIMENTAL
Drug: TOK-001

1950 mg TOK-001, split dose

EXPERIMENTAL
Drug: TOK-001

2600 mg TOK-001

EXPERIMENTAL
Drug: TOK-001

2600 mg TOK-001, split dose

EXPERIMENTAL
Drug: TOK-001

Interventions

TOK-001DRUG

2 capsules (325 mg each), once per day

Also known as: Dose Group 1
650 mg TOK-001

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent form
  • Confirmed cancer of the prostate
  • Progressing disease in spite of androgen ablation therapy
  • Able to swallow multiple capsules

You may not qualify if:

  • Participation in another clinical trial \< 4 weeks prior to enrollment
  • Metastatic disease with one or more of the following:
  • Liver involvement
  • Bone pain associated with confirmed evidence of metastases
  • Non-hepatic visceral involvement
  • The following medications:
  • Prior treatment with MDV3100, abiraterone, Provenge or TAK700
  • Prior treatment with ketoconazole
  • Prior treatment with chemotherapy
  • Prior radiation therapy completed ≤ 4 weeks prior to enrollment
  • The following medical conditions:
  • Active angina pectoris
  • History of Hepatitis B or Hepatitis C
  • Known HIV infection
  • Ongoing hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA

Los Angeles, California, 90095, United States

Location

San Bernardino Urological Associates

San Bernardino, California, 92404, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Comprehensive Cancer Centers of Nevada & US Oncology Research

Las Vegas, Nevada, 89169, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Greenville Hospital System University Medical Center

Greenville, South Carolina, 29605, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • R. B. Montgomery, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • M. E. Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

US(8)