Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
NCT00539968CI-TRIAL-00016791terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer agents are used in combination. Patients with tumors for which treatment with docetaxel would be appropriate are eligible. A second part of the study will further examine the effectiveness of the combination treatment in men with prostate cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel plus lonafarnib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel plus lonafarnib (single arm)
- description
- Docetaxel plus lonafarnib
- interventionNames
- Drug: Docetaxel plus lonafarnib
Primary outcomes (2)
- measure
- Incidence of adverse events and dose-limiting toxicities
- timeFrame
- Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
- measure
- Rate of prostate-specific antigen (PSA) responses
- timeFrame
- Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.