Renal Cell CarcinomaPhase 1NCT01625936
CRLX101 Plus Bevacizumab in Advanced RCC
A Phase 1 study testing CRLX101 (Cerulean) and Bevacizumab in people with Renal Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- CRLX101 (Cerulean) and Bevacizumab
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 16 Jul 2018
- 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
- Patients must have histologically confirmed metastatic or locally advanced renal cell carcinoma that is unresectable.
- Patients must have disease that is evaluable by the Response Evaluation Criteria in Solid Tumors guidelines (RECIST), v1.1. Disease sites must be assessed within 4 weeks of study entry.
- Patients must have been treated with at least one prior conventional molecularly targeted therapy in a non-adjuvant setting. Conventional molecularly targeted therapy will be defined as including pazopanib, sorafenib, sunitinib, temsirolimus, axitinib, or everolimus.
- A two week wash out is required between the last dose of molecularly targeted therapy and baseline correlative studies (124I-cG250 PET/CT and bone marrow biopsy). If no baseline correlative studies will be performed, a wash out of 1 week will be required prior to the commencement of study therapy. Toxicities from prior therapy must be resolved to grade 1 or less prior to the start of study therapy.
- Patients may have been treated with surgery or not (i.e., cytoreductive nephrectomy not required), radiation therapy, chemotherapy, cytokine therapy including interferon alpha and interleukin-2.
- Patients with treated brain or spinal-associated metastases are eligible but must have concluded dexamethasone therapy and be considered neurologically stable.
Show all 12Show fewer
- Age greater or equal to 18 years.
- ECOG performance status less than 1 (Karnofsky greater than 70%)
- Life expectancy greater than 3 months.
- Patients must have normal organ and marrow function
- The effects of CRLX101 and bevacizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of administration of this combination therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of administration of this combination therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had conventional chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not yet recovered to grade 1 or less prior treatment-related adverse events.
- Patients who have had major surgery within the last 4 weeks.
- Prior treatment with bevacizumab or topoisomerase I therapy.
- Patients who are receiving any other investigational therapeutic agent.
- History of allergic reactions attributed to any of the experimental compounds examined in this study.
- No other active malignancy (inactive / without progression for at least 6 months and no progression anticipated).
Show all 11Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of non-healing wounds or ulcers.
- Pregnant or nursing patients as stated above. Agents examined in this clinical trial carry the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on study.
- Bevacizumab has been associated with the development of treatment-related hypertension that can become urgent or emergent. Evidence of uncontrolled hypertension in patients prior to study enrollment will preclude enrollment onto this study until blood pressure is controlled. Uncontrolled hypertension is defined as the presence of systolic blood pressure greater or equal to 150 mmHg or diastolic blood pressure greater or equal to 100 mmHg measured on two separate occasions.
- Patients with known HIV or with solid organ transplant (because of potential additional risk for cytopenias).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase 1b Study Of CRLX 101 (Cerulean) In Combination With Bevacizumab In The Treatment Of Patients With Advanced Renal Cell Carcinoma
This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania.
Read the detailed description
This is a Phase 1b, dose-escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with Bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania. This study also involved two sub-studies that will be conducted in a select set of study subjects. This includes investigational cG250 PET/CT scans and paired bone marrow biopsy/aspirate assessments. The IND being requested from the FDA for this study will cover both the use of CRLX 101 as well as the use cG250 in the study sub-study.
- Conditions
- Renal Cell Carcinoma
- Being tested
- CRLX101 (Cerulean), Bevacizumab
- Keywords
- metastatic, locally advanced, unresectable
- 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.
CRLX101 (Cerulean)Drug
CRLX101 is an innovative tumor-targeting nanopharmaceutical.
BevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion1 Jul 2017
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi M Haas, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625936
- Sponsor's protocol ID
- UPCC 02812
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2012
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study Of CRLX 101 (Cerulean) In Combination With Bevacizumab In The Treatment Of Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01625936
- Acronym / sponsor ID
- UPCC 02812
- Conditions
- Renal Cell Carcinoma
- Keywords
- metastatic, locally advanced, unresectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 22 Jun 2012 (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 Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania.
Detailed description
This is a Phase 1b, dose-escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with Bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania. This study also involved two sub-studies that will be conducted in a select set of study subjects. This includes investigational cG250 PET/CT scans and paired bone marrow biopsy/aspirate assessments. The IND being requested from the FDA for this study will cover both the use of CRLX 101 as well as the use cG250 in the study sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically confirmed metastatic or locally advanced renal cell carcinoma that is unresectable.
- Patients must have disease that is evaluable by the Response Evaluation Criteria in Solid Tumors guidelines (RECIST), v1.1. Disease sites must be assessed within 4 weeks of study entry.
- Patients must have been treated with at least one prior conventional molecularly targeted therapy in a non-adjuvant setting. Conventional molecularly targeted therapy will be defined as including pazopanib, sorafenib, sunitinib, temsirolimus, axitinib, or everolimus.
- A two week wash out is required between the last dose of molecularly targeted therapy and baseline correlative studies (124I-cG250 PET/CT and bone marrow biopsy). If no baseline correlative studies will be performed, a wash out of 1 week will be required prior to the commencement of study therapy. Toxicities from prior therapy must be resolved to grade 1 or less prior to the start of study therapy.
- Patients may have been treated with surgery or not (i.e., cytoreductive nephrectomy not required), radiation therapy, chemotherapy, cytokine therapy including interferon alpha and interleukin-2.
Key exclusion criteria (11 listed)
- Patients who have had conventional chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not yet recovered to grade 1 or less prior treatment-related adverse events.
- Patients who have had major surgery within the last 4 weeks.
- Prior treatment with bevacizumab or topoisomerase I therapy.
- Patients who are receiving any other investigational therapeutic agent.
- History of allergic reactions attributed to any of the experimental compounds examined in this study.
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 |
|---|---|---|
| CRLX101 (Cerulean)CRLX101 is an innovative tumor-targeting nanopharmaceutical. | Drug | – |
| Bevacizumab | Drug | – |
Primary outcome
Number of Adverse Events
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 29 Aug 2018.
Related trials for Renal Cell Carcinoma
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Active, not recruitingPhase 1/2
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 2
Prospective Study of Cadonilimab With Lenvatinib in Renal Cell Carcinoma
Renal Cell Carcinoma (Kidney Cancer), Clear Cell 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.
Naomi M Haas, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 CRLX101 (Cerulean) and Bevacizumab in people with Renal Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine 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 12 inclusion and 11 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 29 Aug 2018. 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.
What does the primary outcome measure?
Number of Adverse Events. 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 29 Aug 2018.