Carcinoma, Renal CellPhase 2NCT00106613
A Research Study for Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing FK228 (romidepsin) in people with Carcinoma, Renal Cell and Neoplasm Metastasis, run by Celgene at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Neoplasm Metastasis
- What is being tested?
- FK228 (romidepsin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2003to 1 Aug 2004
- 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
- Patients must fulfill all of the following criteria to be eligible for study participation:
- Age ≥ 18 years;
- Histologically confirmed Renal Cell Carcinoma (RCC);
- Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
- Failure of prior cytokine therapy;
- Documented progressive disease;
Who cannot join
- Patients are ineligible for entry if any of the following criteria are met:
- Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
- History of serious ventricular arrhythmia
- Corrected QT interval (QTc) ≥ 500 msec
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
- Previous extensive radiotherapy involving ≥ 30% of bone marrow
- Coexistent second malignancy or history of prior malignancy within previous 5 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
- Conditions
- Carcinoma, Renal Cell, Neoplasm Metastasis
- Being tested
- FK228 (romidepsin)
- Keywords
- Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK228 (romidepsin)Drug
Also called romidepsin
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| FK228 (romidepsin) | Experimental | 13 mg/m2 of romidepsin Receives: Drug: FK228 (romidepsin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Measured: Up to 6 months
Secondary outcomes (5)
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Measured: Up to 6 months
Time to objective disease progression.
Measured: Up to 6 months
Number of Participants with Adverse Events
Measured: Up to 6 months
Change from screening assessment to the final study visit in Karnofsky performance status.
Measured: Up to 6 months
Steady state plasma concentrations
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2005 (estimated)
- Study start1 May 2003
- Primary completion1 Aug 2004
- Study completion1 Aug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William McCulloch, MB, FRCP, Study director, Gloucester Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106613
- Sponsor's protocol ID
- FJ-228-0001
- Status last verified
- Oct 2019
- First submitted
- 28 Mar 2005
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.
PubMed 29936064Wolchok J. Putting the Immunologic Brakes on Cancer. Cell. 2018 Nov 29;175(6):1452-1454. doi: 10.1016/j.cell.2018.11.006.
PubMed 30500529Mansfield AS, Jen J. Predicting Treatment Response Based on RNA Expression in Large Datasets. Clin Cancer Res. 2019 Mar 1;25(5):1443-1445. doi: 10.1158/1078-0432.CCR-18-2823. Epub 2018 Nov 16.
PubMed 30446588Pal SK, Forero-Torres A, Thompson JA, Morris JC, Chhabra S, Hoimes CJ, Vogelzang NJ, Boyd T, Bergerot PG, Adashek JJ, Li H, Yu X, Gartner EM, Carret AS, Smith DC. A phase 1 trial of SGN-CD70A in patients with CD70-positive, metastatic renal cell carcinoma. Cancer. 2019 Apr 1;125(7):1124-1132. doi: 10.1002/cncr.31912. Epub 2019 Jan 9.
PubMed 30624766Stadler W, et al. A phase II study of depsipeptide (Dep) in patients (pts) with metastatic renal cell cancer (RCC). J Clin Oncol. 2005 Jun; 23(16_suppl):4669.
Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer. 2006 Jun;5(1):57-60. doi: 10.3816/CGC.2006.n.018.
PubMed 16859580
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
- ClinicalTrials.gov ID
- NCT00106613
- Acronym / sponsor ID
- FJ-228-0001
- Conditions
- Carcinoma, Renal Cell, Neoplasm Metastasis
- Keywords
- Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 May 2003 (actual)
- Primary completion
- 1 Aug 2004 (actual)
- Study completion
- 1 Aug 2004 (actual)
- First posted
- 29 Mar 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 evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FK228 (romidepsin) | Experimental | Drug: FK228 (romidepsin)13 mg/m2 of romidepsin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must fulfill all of the following criteria to be eligible for study participation:
- Age ≥ 18 years;
- Histologically confirmed Renal Cell Carcinoma (RCC);
- Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
- Failure of prior cytokine therapy;
Key exclusion criteria (7 listed)
- Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
- History of serious ventricular arrhythmia
- Corrected QT interval (QTc) ≥ 500 msec
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
- Previous extensive radiotherapy involving ≥ 30% of bone marrow
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 |
|---|---|---|
| FK228 (romidepsin)Also: romidepsinPatients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle. | Drug | FK228 (romidepsin) |
Primary outcome
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Time frame: Up to 6 months
5 secondary outcomes
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Time frame: Up to 6 months
Time to objective disease progression.
Time frame: Up to 6 months
Number of Participants with Adverse Events
Time frame: Up to 6 months
Change from screening assessment to the final study visit in Karnofsky performance status.
Time frame: Up to 6 months
Steady state plasma concentrations
Time frame: Up to 6 months
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 18 Oct 2019.
- Background: PubMed 29936064Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.
- Background: PubMed 30500529Wolchok J. Putting the Immunologic Brakes on Cancer. Cell. 2018 Nov 29;175(6):1452-1454. doi: 10.1016/j.cell.2018.11.006.
- Background: PubMed 30446588Mansfield AS, Jen J. Predicting Treatment Response Based on RNA Expression in Large Datasets. Clin Cancer Res. 2019 Mar 1;25(5):1443-1445. doi: 10.1158/1078-0432.CCR-18-2823. Epub 2018 Nov 16.
- Background: PubMed 30624766Pal SK, Forero-Torres A, Thompson JA, Morris JC, Chhabra S, Hoimes CJ, Vogelzang NJ, Boyd T, Bergerot PG, Adashek JJ, Li H, Yu X, Gartner EM, Carret AS, Smith DC. A phase 1 trial of SGN-CD70A in patients with CD70-positive, metastatic renal cell carcinoma. Cancer. 2019 Apr 1;125(7):1124-1132. doi: 10.1002/cncr.31912. Epub 2019 Jan 9.
- BackgroundStadler W, et al. A phase II study of depsipeptide (Dep) in patients (pts) with metastatic renal cell cancer (RCC). J Clin Oncol. 2005 Jun; 23(16_suppl):4669.
- Results publication: PubMed 16859580Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer. 2006 Jun;5(1):57-60. doi: 10.3816/CGC.2006.n.018.
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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.
William McCulloch, MB, FRCP study director
Gloucester Pharmaceuticals Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK228 (romidepsin) in people with Carcinoma, Renal Cell and Neoplasm Metastasis, run by Celgene at 3 sites 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 6 inclusion and 7 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106613, which also lists 6 linked publications.
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 18 Oct 2019.