Prostate CancerPhase 1/2NCT00539968
A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
A Phase 1/2 study testing Docetaxel plus lonafarnib in people with Prostate Cancer and Breast Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Ovarian Cancer
- What is being tested?
- Docetaxel plus lonafarnib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
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
- Prostate Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Gastric Cancer
- Being tested
- Docetaxel plus lonafarnib
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel plus lonafarnibDrug
Also called Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)
Docetaxel: 60-75 mg/m2
Lonafarnib: 150-375 mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus lonafarnib (single arm) | Experimental | Docetaxel plus lonafarnib Receives: Drug: Docetaxel plus lonafarnib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and dose-limiting toxicities
Measured: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Rate of prostate-specific antigen (PSA) responses
Measured: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Secondary outcomes (3)
Proportion of subjects with dose-limiting toxicities
Measured: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Plasma lonafarnib concentrations
Measured: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
RECIST-defined radiological response rate
Measured: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539968
- Sponsor's protocol ID
- P04467
- Status last verified
- Feb 2015
- First submitted
- 4 Oct 2007
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
- ClinicalTrials.gov ID
- NCT00539968
- Acronym / sponsor ID
- P04467
- Conditions
- Prostate Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus lonafarnib (single arm) | Experimental | Drug: Docetaxel plus lonafarnibDocetaxel plus lonafarnib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel plus lonafarnibAlso: Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)Docetaxel: 60-75 mg/m2 Lonafarnib: 150-375 mg PO BID | Drug | Docetaxel plus lonafarnib (single arm) |
Primary outcome
Incidence of adverse events and dose-limiting toxicities
Time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Rate of prostate-specific antigen (PSA) responses
Time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
3 secondary outcomes
Proportion of subjects with dose-limiting toxicities
Time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Plasma lonafarnib concentrations
Time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
RECIST-defined radiological response rate
Time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel plus lonafarnib in people with Prostate Cancer and Breast Cancer, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and dose-limiting toxicities (time frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.