Carcinoma, Non-small-cell LungPhase 3NCT00050336
Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
A Phase 3 study testing Lonafarnib (SARASAR) in people with Carcinoma, Non-small-cell Lung and Metastases, Neoplasm, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
- What is being tested?
- Lonafarnib (SARASAR)
- How many people
- 702 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Mar 2004
- Phase
- Phase 3
- 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
- Male or female
- Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
- Age greater than or equal to 18 years old
- ECOG performance status of 0 to 1
- Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
- Meets protocol requirements for specified laboratory values
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- Written informed consent
- Appropriate use of effective contraception if of childbearing potential
- Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease
Who cannot join
- Prior chemotherapy for any stage of NSCLC
- Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
- Concurrent treatment or treatment within the last 2 years for any other malignancy
- Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
- Medical conditions that would interfere with taking oral medications
- Patients with bone metastases as the only site of disease
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- Pregnant or nursing women
- Known HIV positivity or AIDS-related illness
- Patients with significant QTc prolongation at baseline
About this study
Official title: A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.
- Being tested
- Lonafarnib (SARASAR)
- Keywords
- Stage 3b or 4 (metastatic) non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lonafarnib (SARASAR)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2002 (estimated)
- Study startDec 2002
- Primary completionFeb 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-small-cell LungStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 702 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
- NCT00050336
- Sponsor's protocol ID
- P01901
- Status last verified
- Aug 2015
- First submitted
- 4 Dec 2002
- Last updated
- 27 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00050336
- Acronym / sponsor ID
- P01901
- Keywords
- Stage 3b or 4 (metastatic) non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 5 Dec 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 overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
- Age greater than or equal to 18 years old
- ECOG performance status of 0 to 1
- Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
Key exclusion criteria (9 listed)
- Prior chemotherapy for any stage of NSCLC
- Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
- Concurrent treatment or treatment within the last 2 years for any other malignancy
- Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
- Medical conditions that would interfere with taking oral medications
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 |
|---|---|---|
| Lonafarnib (SARASAR) | 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 27 Aug 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 3 study testing Lonafarnib (SARASAR) in people with Carcinoma, Non-small-cell Lung and Metastases, Neoplasm, 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 9 inclusion and 9 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 27 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 27 Aug 2015.