Solid TumorsEarly Phase 1NCT02157831
Redosing With CP-870, 893 in Patients With Clinical Benefit After a Single Infusion From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors
A Early Phase 1 study testing CP-870,893 in people with Solid Tumors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CP-870,893
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2008
- Phase
- Early 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
- Clinical benefit, including stable disease, partial response, or complete response, without a dose-limiting toxicity after a single infusion of CP-870,893; however, patients who experienced transient, not serious, and fully reversible grade 1-3 increases in ALT or AST after one dose of CP-870,893 may, if otherwise eligible, receive a second dose on this protocol.
- Age at least 18 years old;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
- Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
- White blood cell (WBC) count >3000 cells/μL without growth factor support;
- Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
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- Platelets >100,000/μL without growth factor support; and
- Hemoglobin ≥10 g/dL.
- Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
- Total bilirubin <1.5 times the upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <2.5 × ULN;
- Creatinine clearance (CLcr, measured or calculated) >80 mL/min; and
- Life expectancy of at least 12 weeks;
- Signed written informed consent.
Who cannot join
- Concurrent treatment with any anticancer agent;
- History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory bowel disease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
- Treatment with any other cancer therapy from the time of the first dose of CP-870,893, except as noted in Section 4.4; 1 Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. 31 Mar 2003 (http://ctep.cancer.gov).
- History of congestive heart failure, stroke, or myocardial infarction;
- Hereditary or acquired coagulopathies (e.g. hemophilia, von Willebrand's disease, cancer-associated DIC);
- Brain metastases.
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- Patient having reproductive potential who is not using an effective method of birth control or who is pregnant or breastfeeding or has a positive (urine or serum) pregnancy test at baseline;
- Known sensitivity to immunomodulating agents or monoclonal antibodies;
- Alcohol abuse or illicit drug use within 12 months of enrollment;
- History of serum creatinine ≥2 mg/dL for any duration and for any reason;
- Urine dipstick 1+ or more positive for blood (other than menstruating females) or 2+ or more positive for protein;
- Positive HAHA antibody titer in response to treatment with first dose of CP-870,893 (as determined by Pfizer)
- Clinically significant presence of granular or cellular casts in centrifuged urine sediment;
- Renal carcinoma or renal metastases;
- Partial or complete nephrectomy;
- History of dialysis (peritoneal or hemodialysis);
- Prior treatment with Amphotericin B or cisplatin;
- History of insulin-dependent diabetes for greater than 5 years;
- Concomitant treatment with systemic corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
- Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
- Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (e.g., rituximab or immunoglobulin G);
- Ongoing or active infection;
- Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections. Topical use of antibiotics or antifungals is allowed;
- Other uncontrolled concurrent illness that would preclude study participation; or Psychiatric illness or social situation that would preclude study participation.
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: Redosing With CP-870,893 in Patients With Clinical Benefit After a Single Infusion of CP-870,893 From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors
Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously.
- Conditions
- Solid Tumors
- Being tested
- CP-870,893
- Keywords
- Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-870,893Biological
| Study group | Role | What they receive |
|---|---|---|
| Subjects from UPCC 10903 | Experimental | Not described Receives: Biological: CP-870,893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJul 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Vonderheide, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157831
- Sponsor's protocol ID
- UPCC 10904
- Status last verified
- Aug 2018
- First submitted
- 4 Jun 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redosing With CP-870,893 in Patients With Clinical Benefit After a Single Infusion of CP-870,893 From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02157831
- Acronym / sponsor ID
- UPCC 10904
- Conditions
- Solid Tumors
- Keywords
- Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Jun 2014 (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.
Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects from UPCC 10903 | Experimental | Biological: CP-870,893 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Clinical benefit, including stable disease, partial response, or complete response, without a dose-limiting toxicity after a single infusion of CP-870,893; however, patients who experienced transient, not serious, and fully reversible grade 1-3 increases in ALT or AST after one dose of CP-870,893 may, if otherwise eligible, receive a second dose on this protocol.
- Age at least 18 years old;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
- Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
- White blood cell (WBC) count >3000 cells/μL without growth factor support;
Key exclusion criteria (24 listed)
- Concurrent treatment with any anticancer agent;
- History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory bowel disease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
- Treatment with any other cancer therapy from the time of the first dose of CP-870,893, except as noted in Section 4.4; 1 Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. 31 Mar 2003 (http://ctep.cancer.gov).
- History of congestive heart failure, stroke, or myocardial infarction;
- Hereditary or acquired coagulopathies (e.g. hemophilia, von Willebrand's disease, cancer-associated DIC);
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-870,893 | Biological | Subjects from UPCC 10903 |
Primary outcome
Number of Adverse Events
Time frame: 8 weeks
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 17 Aug 2018.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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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 Vonderheide, 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 Early Phase 1 study testing CP-870,893 in people with Solid Tumors, 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 14 inclusion and 24 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 17 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 (time frame: 8 weeks). 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 17 Aug 2018.