NeoplasmsPhase 1NCT00040534
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
A Phase 1 study testing Farnesyl Protein Transferase Inhibitor in people with Neoplasms, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Farnesyl Protein Transferase Inhibitor
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Jul 2004
- Phase
- Phase 1
- 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
- Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
- Age greater than or equal to 18.
- SWOG performance Status less than or equal to 2.
- Meets protocol requirements for specified laboratory values.
- Written informed consent and cooperation of patient.
Who cannot join
- Prior treatment with an FPTI
- Knowledge of intracranial metastases or carcinomatous meningitis.
- Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
- Medical conditions that would interfere with taking oral medications.
- Significant uncontrolled diarrhea.
- Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment.
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- Concomitant use of CYP3A inhibitors/inducers per protocol.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- Men or women of childbearing potential who are not using an effective method of contraception.
- Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
- QTc prolongation (>440 msecs) at baseline.
- Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to >30% of bone marrow-containing areas.
- Patients that have received Mitomycin-C or nitrosoureas.
About this study
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase
Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer.
- Conditions
- Neoplasms
- Being tested
- Farnesyl Protein Transferase Inhibitor
- Keywords
- Advanced Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farnesyl Protein Transferase InhibitorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2002 (estimated)
- Study startJan 2001
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT00040534
- Sponsor's protocol ID
- P01499
- Status last verified
- Feb 2015
- First submitted
- 28 Jun 2002
- Last updated
- 16 Feb 2015
- Results posted
- No
Publications
Chow LQ, Eckhardt SG, O'Bryant CL, Schultz MK, Morrow M, Grolnic S, Basche M, Gore L. A phase I safety, pharmacological, and biological study of the farnesyl protein transferase inhibitor, lonafarnib (SCH 663366), in combination with cisplatin and gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008 Sep;62(4):631-46. doi: 10.1007/s00280-007-0646-x. Epub 2007 Dec 6.
PubMed 18058098
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
- ClinicalTrials.gov ID
- NCT00040534
- Acronym / sponsor ID
- P01499
- Conditions
- Neoplasms
- Keywords
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 1 Jul 2002 (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.
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase
Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
- Age greater than or equal to 18.
- SWOG performance Status less than or equal to 2.
- Meets protocol requirements for specified laboratory values.
- Written informed consent and cooperation of patient.
Key exclusion criteria (14 listed)
- Prior treatment with an FPTI
- Knowledge of intracranial metastases or carcinomatous meningitis.
- Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
- Medical conditions that would interfere with taking oral medications.
- Significant uncontrolled diarrhea.
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 |
|---|---|---|
| Farnesyl Protein Transferase Inhibitor | Drug | – |
Primary outcome
Not reported in the source record.
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 16 Feb 2015.
- Results publication: PubMed 18058098Chow LQ, Eckhardt SG, O'Bryant CL, Schultz MK, Morrow M, Grolnic S, Basche M, Gore L. A phase I safety, pharmacological, and biological study of the farnesyl protein transferase inhibitor, lonafarnib (SCH 663366), in combination with cisplatin and gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008 Sep;62(4):631-46. doi: 10.1007/s00280-007-0646-x. Epub 2007 Dec 6.
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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 study testing Farnesyl Protein Transferase Inhibitor in people with Neoplasms, 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 5 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 16 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00040534, which also lists 1 linked publication.
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 16 Feb 2015.