Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00006085
CP-609,754 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing CP-609,754 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- CP-609,754
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to 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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor No standard curative therapy exists OR Refractory OR Disease progression while on therapy Measurable disease No brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior hemorrhagic or thrombotic cerebrovascular events including transient ischemic attacks No clinically significant or unstable cardiac disease No myocardial infarction within past 6 months No serious cardiac arrhythmia or conduction abnormality Pulmonary: No chronic obstructive pulmonary disease requiring hospitalization within past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception Female patients must use barrier contraception plus a second form of effective contraception for at least 3 months prior to and during study No other serious concurrent systemic disorders that would preclude study No uncontrolled diabetes mellitus, thyroid disease, or seizure disorder No active neurologic or psychiatric disease No clinically apparent uncontrolled infection (e.g., HIV, hepatitis B or C) No known sensitivity to imidazole containing drugs (e.g., clotrimazole, oxiconazole, sulconazole, econazole, etoconazole, metronidazole, or ketoconazole) No clinically significant gastrointestinal abnormalities requiring intravenous alimentation No malabsorption syndrome or active peptic ulcer No other lab abnormalities (i.e., electrolytes, uric acid, calcium, phosphorous, or glucose) that would preclude study No other malignancy in past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the breast or cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No prior bone marrow transplantation Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for carboplatin, nitrosoureas, or mitomycin) and recovered Endocrine therapy: At least 1 week since prior hormonal therapy and recovered Concurrent hormone replacement therapy allowed No concurrent chronic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to study lesions or to more than 30% of bone marrow containing areas Surgery: Not specified Other: At least 4 weeks since other prior investigational drugs No other concurrent investigational drugs Any regimens for other concurrent diseases or medical conditions must be stable for at least 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
About this study
Official title: Phase I Open-Label Study of the Safety, Toleration and Pharmacokinetics of CP-609,754, a Farnesyl Transferase Inhibitor, in Subjects With Advanced Malignant Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the safety, tolerability, pharmacokinetics, and maximum tolerated dose of CP-609,754 in patients with advanced solid tumors. II. Determine the predictability, duration, intensity, onset, reversibility, and dose relationship of any observed toxicities in these patients when treated with this regimen. III. Determine any preliminary evidence of antitumor activity of this treatment as assessed by response rate and time to disease progression in this patient population.
OUTLINE: This is a dose escalation study. Patients receive oral CP-609,754 1-2 times daily. Treatment continues every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-609,754 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 44-56 patients will be accrued for this study within 12 months.
- Being tested
- CP-609,754
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-609,754Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Daniel M. Sullivan, MD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006085
- Sponsor's protocol ID
- CDR0000068077
- Other IDs
- MCC-12222, PFIZER-A3321001, NCI-G00-1824
- Status last verified
- Dec 2001
- First submitted
- 3 Aug 2000
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-Label Study of the Safety, Toleration and Pharmacokinetics of CP-609,754, a Farnesyl Transferase Inhibitor, in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT00006085
- Acronym / sponsor ID
- CDR0000068077
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2000
- First posted
- 16 Mar 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: I. Determine the safety, tolerability, pharmacokinetics, and maximum tolerated dose of CP-609,754 in patients with advanced solid tumors. II. Determine the predictability, duration, intensity, onset, reversibility, and dose relationship of any observed toxicities in these patients when treated with this regimen. III. Determine any preliminary evidence of antitumor activity of this treatment as assessed by response rate and time to disease progression in this patient population.
OUTLINE: This is a dose escalation study. Patients receive oral CP-609,754 1-2 times daily. Treatment continues every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-609,754 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 44-56 patients will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CP-609,754 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Daniel M. Sullivan, MD study chair
H. Lee Moffitt Cancer Center and Research Institute
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 CP-609,754 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by H. Lee Moffitt Cancer Center and Research Institute 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?
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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. 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?
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 19 Dec 2013.