Carcinoma, Renal CellPhase 2NCT00134186
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
A Phase 2 study testing motexafin gadolinium in people with Carcinoma, Renal Cell and Urogenital Neoplasms, run by Pharmacyclics LLC. at 1 site in United States.
Trial summary
The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms
- What is being tested?
- motexafin gadolinium
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 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
- ≥ 18 years old
- Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
- Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
- Measurable disease
- Hemoglobin ≥ 9 mg/dL
- ECOG performance status of 0, 1, or 2
- Willing and able to provide written informed consent
Who cannot join
- Inadequate bone marrow, renal and liver function by laboratory criteria
- Absolute neutrophil count < 1500/µL;
- Platelet count < 100,000/µL;
- AST or ALT > 2 x upper limit of normal (ULN);
- Alkaline phosphatase > 5 x ULN;
- Total bilirubin > 2 x ULN;
Show all 10Show fewer
- Creatinine > 2.0 mg/dL.
- Evidence of central nervous system metastases within past year
- Uncontrolled hypertension
- Known history of porphyria, G6PD deficiency or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma
The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).
- Being tested
- motexafin gadolinium
- Keywords
- Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
- Medical subject headings
- Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motexafin gadoliniumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Secondary outcomes (5)
Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
Time to progression
Progression-free survival
Overall survival and survival at 6 and 12 months
Duration of clinical response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert J Amato, D.O., Principal investigator, Methodist Hospital Genitourinary Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134186
- Sponsor's protocol ID
- PCYC-0219
- Status last verified
- Mar 2007
- First submitted
- 22 Aug 2005
- Last updated
- 5 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00134186
- Acronym / sponsor ID
- PCYC-0219
- Keywords
- Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- First posted
- 24 Aug 2005 (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 find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (7 listed)
- ≥ 18 years old
- Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
- Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
- Measurable disease
- Hemoglobin ≥ 9 mg/dL
Key exclusion criteria (10 listed)
- Inadequate bone marrow, renal and liver function by laboratory criteria
- Evidence of central nervous system metastases within past year
- Uncontrolled hypertension
- Known history of porphyria, G6PD deficiency or HIV
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 |
|---|---|---|
| motexafin gadolinium | Drug | – |
Primary outcome
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
5 secondary outcomes
Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
Time to progression
Progression-free survival
Overall survival and survival at 6 and 12 months
Duration of clinical response
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 5 Mar 2007.
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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.
Robert J Amato, D.O. principal investigator
Methodist Hospital Genitourinary Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing motexafin gadolinium in people with Carcinoma, Renal Cell and Urogenital Neoplasms, run by Pharmacyclics LLC. 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 7 inclusion and 10 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 5 Mar 2007. 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 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 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.
What does the primary outcome measure?
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma). 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 Mar 2007.