MetastasesPhase 1NCT00034463
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
A Phase 1 study testing ALIMTA, folic acid and multi-vitamins in people with Metastases and Cancer, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases, Cancer
- What is being tested?
- ALIMTA, folic acid and multi-vitamins
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Histologic or cytologic diagnosis of metastatic or locally advanced cancer
- Prior chemotherapy is allowed
- Adequate bone marrow, liver and kidney function
Who cannot join
- Prior treatment with ALIMTA
- Brain metastasis
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
San Antonio, Texas
About this study
Official title: A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.
- Conditions
- Metastases, Cancer
- Being tested
- ALIMTA, folic acid, multi-vitamins
- Keywords
- metastatic cancer, chemotherapy
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIMTADrug
folic acidDrug
multi-vitaminsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034463
- Sponsor's protocol ID
- 1310
- Other IDs
- H3E-MC-JMAS
- Status last verified
- Jul 2006
- First submitted
- 29 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00034463
- Acronym / sponsor ID
- 1310
- Conditions
- Metastases, Cancer
- Keywords
- metastatic cancer, chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 30 Apr 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.
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic or cytologic diagnosis of metastatic or locally advanced cancer
- Prior chemotherapy is allowed
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (3 listed)
- Prior treatment with ALIMTA
- Brain metastasis
- Pregnancy or breast feeding
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 |
|---|---|---|
| ALIMTA | Drug | – |
| folic acid | Drug | – |
| multi-vitamins | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2006.
Related trials for Metastases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALIMTA, folic acid and multi-vitamins in people with Metastases and Cancer, run by Eli Lilly and Company at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 19 Jul 2006.