ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer

Ltn Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: TOK-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959959

TOK-200-05

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 8 patient groups

650 mg TOK-001

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

1300 mg TOK-001

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

1950 mg TOK-001

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

975 mg TOK-001

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

975 mg TOK-001, supplement

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

1950 mg TOK-001, split dose

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

2600 mg TOK-001

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

2600 mg TOK-001, split dose

Experimental group

Treatment:

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001

Drug: TOK-001