Metastatic Renal Cell CarcinomaPhase 2NCT00444314
Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing Panzem® NCD and Sunitinib Malate in people with Metastatic Renal Cell Carcinoma, run by CASI pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Panzem® NCD and Sunitinib Malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Oct 2009
- 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 have a histologically confirmed renal cell cancer with a component of clear cell carcinoma and evidence of metastasis (pure sarcomatoid variant cancers and collecting duct malignancies will be excluded).
- Patients must have measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 2 times the slice width with spiral CT scan (i.e. 10 mm if the CT slice width is 5 mm, 14 mm if the CT slice width is 7 mm).
- Patients must have previously received or be currently receiving sunitinib malate (Sutent) with evidence of disease progression while receiving sunitinib malate (as evident by new lesions on CT/MRI/bone scan or unequivocal growth in measurable tumor lesions).
- Note: Patients will be stratified to:
- A: Patients previously treated with sunitinib malate. At least 4 week washout since last treatment administered is required before patient is eligible for study. Once patients meet all other eligibility criteria, they will be treated with Panzem® NCD alone.
- B: Patients currently still on sunitinib. Patients will continue to receive their current dose/schedule of sunitinib. Once eligibility determined, patients will be started on Panzem® NCD concurrently with their sunitinib. No drug washout of sunitinib malate is required for this stratification.
Show all 21Show fewer
- Note: Enrollment to the individual stratification will stop once that stratification has met its accrual goal.
- Age greater than or equal to 18 years.
- Life expectancy of greater than 3 months.
- ECOG performance status 0-2 (see Appendix A).
- Patients must have normal organ and marrow function as defined below:
- leukocytes greater than or equal to 3,000/μL
- absolute neutrophil count greater than or equal to 1,200/μL
- hemoglobin greater than or equal to 9.0 g/dl (patient may be transfused to this level)
- platelets greater than or equal to 100,000/μL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT)less than or equal to 2.5 X institutional upper limit of normal
- creatinine less than or equal to 1.5 x institutional upper limit of normal
- Adequate cardiac function by history. If the patient has any history of cardiac disease (prior myocardial infarction, congestive heart failure, etc.), a normal echocardiogram or multigated acquisition (MUGA) scan will be required (LVEF greater than or equal to institutional lower limit of normal).
- No evidence for uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The systolic blood pressure must be less than or equal to 140 mmHg and the diastolic blood pressure less than or equal to 90 mmHg. Patients are allowed to be on anti-hypertensive medications.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- No major surgery, radiotherapy, chemotherapy, cytokine therapy or other experimental therapy is permitted within 4 weeks of treatment initiation. Patients must recover to baseline or grade 1 from any clinically significant adverse event experienced during those prior therapies.
- Patients may not be concurrently receiving any other investigational agents while participating on this study.
- Patients with active brain metastases are excluded. Previously treated brain metastasis will be allowed provided that the patient is clinically stable (off systemic steroids and not on antiepileptic agents) with a repeat imaging study (within 4 weeks of registration) of the brain confirming stable CNS disease. Patients with known CNS carcinomatosis or leptomeningeal spread of their disease will be excluded from this study due to their poor prognosis.
- Patients with gastrointestinal abnormalities including inability to take oral medications, requirement for intravenous alimentation, and malabsorption syndromes will be excluded.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Show all 9Show fewer
- Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose of more than 10 mmol/L (200 mg/dL) will be excluded due to difficulty evaluating the tumor metabolic activity using FDG-PET.
- History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment.
- History of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent, and disease free for greater than or equal to 5 years.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase II Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion Alone and in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma Progressing on Sunitinib Malate
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Panzem® NCD, Sunitinib Malate
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzem® NCDDrug
NCD suspension, 1500 mg TID daily for 6 week cycles
Sunitinib MalateDrug
Also called Sutent
Sunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Panzem® NCD |
| B | Experimental | Not described Receives: Drug: Panzem® NCD; Drug: Sunitinib Malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the objective response rate of Panzem NCD alone and in combination with Sunitinib Malate
Measured: Throughout study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Glenn Liu, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444314
- Sponsor's protocol ID
- ME-CLN-008
- Status last verified
- Aug 2011
- First submitted
- 6 Mar 2007
- Last updated
- 4 Aug 2011
- Results posted
- No
Publications
Bruce JY, Eickhoff J, Pili R, Logan T, Carducci M, Arnott J, Treston A, Wilding G, Liu G. A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate. Invest New Drugs. 2012 Apr;30(2):794-802. doi: 10.1007/s10637-010-9618-9. Epub 2010 Dec 22.
PubMed 21174224
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion Alone and in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma Progressing on Sunitinib Malate
- ClinicalTrials.gov ID
- NCT00444314
- Acronym / sponsor ID
- ME-CLN-008
- Conditions
- Metastatic Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Mar 2007 (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 open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Panzem® NCD |
| B | Experimental | Drug: Panzem® NCD, Drug: Sunitinib Malate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have a histologically confirmed renal cell cancer with a component of clear cell carcinoma and evidence of metastasis (pure sarcomatoid variant cancers and collecting duct malignancies will be excluded).
- Patients must have measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 2 times the slice width with spiral CT scan (i.e. 10 mm if the CT slice width is 5 mm, 14 mm if the CT slice width is 7 mm).
- Patients must have previously received or be currently receiving sunitinib malate (Sutent) with evidence of disease progression while receiving sunitinib malate (as evident by new lesions on CT/MRI/bone scan or unequivocal growth in measurable tumor lesions).
- A: Patients previously treated with sunitinib malate. At least 4 week washout since last treatment administered is required before patient is eligible for study. Once patients meet all other eligibility criteria, they will be treated with Panzem® NCD alone.
- B: Patients currently still on sunitinib. Patients will continue to receive their current dose/schedule of sunitinib. Once eligibility determined, patients will be started on Panzem® NCD concurrently with their sunitinib. No drug washout of sunitinib malate is required for this stratification.
Key exclusion criteria (9 listed)
- No major surgery, radiotherapy, chemotherapy, cytokine therapy or other experimental therapy is permitted within 4 weeks of treatment initiation. Patients must recover to baseline or grade 1 from any clinically significant adverse event experienced during those prior therapies.
- Patients may not be concurrently receiving any other investigational agents while participating on this study.
- Patients with active brain metastases are excluded. Previously treated brain metastasis will be allowed provided that the patient is clinically stable (off systemic steroids and not on antiepileptic agents) with a repeat imaging study (within 4 weeks of registration) of the brain confirming stable CNS disease. Patients with known CNS carcinomatosis or leptomeningeal spread of their disease will be excluded from this study due to their poor prognosis.
- Patients with gastrointestinal abnormalities including inability to take oral medications, requirement for intravenous alimentation, and malabsorption syndromes will be excluded.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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 |
|---|---|---|
| Panzem® NCDNCD suspension, 1500 mg TID daily for 6 week cycles | Drug | A, B |
| Sunitinib MalateAlso: SutentSunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle | Drug | B |
Primary outcome
To assess the objective response rate of Panzem NCD alone and in combination with Sunitinib Malate
Time frame: Throughout study participation
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 4 Aug 2011.
- Results publication: PubMed 21174224Bruce JY, Eickhoff J, Pili R, Logan T, Carducci M, Arnott J, Treston A, Wilding G, Liu G. A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate. Invest New Drugs. 2012 Apr;30(2):794-802. doi: 10.1007/s10637-010-9618-9. Epub 2010 Dec 22.
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Glenn Liu, MD principal investigator
University of Wisconsin, Madison
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 Panzem® NCD and Sunitinib Malate in people with Metastatic Renal Cell Carcinoma, run by CASI pharmaceuticals, Inc. 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 21 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: finished, as of the sponsor's last update on 4 Aug 2011. 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 assess the objective response rate of Panzem NCD alone and in combination with Sunitinib Malate (time frame: Throughout study participation). 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 NCT00444314, which also lists 1 linked publication.
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 4 Aug 2011.