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An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Gastric Cancer

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Trial Information

An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel


Inclusion Criteria:



- For Part 1: Subjects may be male or female and must be at least 18 years of age.

- For Part 1: Cancer for which docetaxel treatment is appropriate.

- For Part 1: Docetaxel-naïve

- For Part 2: Subjects must be male and at least 18 years of age.

- For Part 2: Subjects must have adenocarcinoma of the prostate confirmed by
histologic/cytologic biopsy.

- For Part 2: Subjects must have progressive, metastatic, AIPC and a PSA of 10 ng/ml or
more after hormonal therapy prior to docetaxel treatment. Progressive disease is
defined as a consistently increasing serum PSA level within 28 days prior to
docetaxel administration.

- Adequate organ function within 3 weeks prior to first study drug administration.

- Performance status (ECOG) is less than or equal to 2.

- Subject understands and agrees to procedures and participation by signing informed
consent form.

- Agrees to use medically accepted form of contraception.

Exclusion Criteria:

- Receipt of or need to continue to receive prohibited medications (listed in the
protocol) more recently than the washout period (indicated in the protocol).

- Surgery within 3 weeks prior to first study drug administration.

- History within 5 years prior to first study drug administration of another malignancy
except adequately treated Stage I/II basal/squamous cell skin cancer.

- Radiation therapy to more than 25% of his/her total bone marrow during life.

- Radiation therapy within 3 weeks prior to first study drug administration.

- Known hypersensitivity to prednisone, docetaxel, polysorbate 80, lonafarnib, or any
excipients associated with these medications.

- Known contraindication to steroid use.

- Known leptomeningeal or CNS metastasis.

- Heart, vascular, or seizure disorder (detailed list in the protocol) within 6 months
prior to first study drug administration.

- Baseline QTc interval greater than 450 msec.

- Grade 2 or more peripheral neuropathy or drug-related toxicity per CTCAE. Exceptions
are noted in the protocol.

- Any clinically significant condition or situation that the investigator thinks would
interfere with the study evaluations or subject's participation.

- Subject is part of staff personnel involved in the study.

- Subject has known clinically significant immunosuppression.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and dose-limiting toxicities

Outcome Time Frame:

Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P04467

NCT ID:

NCT00539968

Start Date:

June 2007

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Gastric Cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

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