TumorsPhase 1NCT00363610
A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma
A Phase 1 study testing Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma in people with Tumors and Lymphoma, run by Enzon Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2006to Jun 2008
- 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
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary treatment or there is no available standard treatment.
- Prior standard therapy was not effective, or no known therapy will extend survival or provide benefit.
- Measurable or evaluable disease.
- Age 18 years or older.
- Score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Show all 15Show fewer
- Absolute neutrophil count (ANC)≥ 1500/μL.
- Platelet count ≥ 100,000/μL.
- Hemoglobin ≥ 9.0 g/dL.
- Fibrinogen ≥ 0.75x the lower limit of normal (LLN), and PT, PTT, and INR ≤ 1.5x the upper limit of normal (ULN).
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
- Total bilirubin ≤ 1.5 mg/dL.
- Transaminases (AST, ALT) ≤ 2.5x the upper limit of normal (ULN) (may be ≤ 5.0x ULN if due to metastatic disease in the liver).
- Amylase and lipase levels are within normal limits.
- Any subject who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the tumor analysis part of the study.
Who cannot join
- Subjects meeting any of the following exclusion criteria will not be eligible for enrollment.
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.
- Has a coagulopathy or a history of coagulopathy.
- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
- Positive screening pregnancy test or is breast-feeding.
Show all 10Show fewer
- Female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
- Known or clinically suspected active brain metastases.
- Received pegaspargase (Oncaspar®, PEG-L-asparaginase) or any asparaginase or asparaginase-containing drug, at any time prior to this study.
- Received prior chemotherapy, immunotherapy or an investigational agent regimen
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Nebraska Medical Center
Omaha, Nebraska, 68198-8511
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, 78229
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma
This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.
Read the detailed description
The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc. ("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's scientific or generic name. Because it is already approved by the Food and Drug Administration (FDA), it also has a brand name - ONCASPAR®. It is approved by the FDA for the treatment of a type of leukemia (cancer of white blood cells). However, pegaspargase is not approved by the FDA for treatment of the cancer in this study. This study will research the side effects of pegaspargase when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl; its brand name is GEMZAR®. It is approved for the treatment of patients with cancer of the pancreas and of patients with breast cancer. However, gemcitabine is not approved by the FDA for treatment of any other types of cancer.
In addition, the combination of pegaspargase and gemcitabine for solid tumors and lymphoma in this study is investigational. This type of study treatment is called a "combination treatment" or a "combination study." The information (research data) from this study will be used by Enzon to plan other "combination" research studies with pegaspargase plus gemcitabine for the treatment of certain cancers.
- Being tested
- Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma
- Keywords
- Advanced and/or Metastatic Solid Tumors and Lymphoma
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncaspar & Gemzar; advanced and/or solid tumors and lymphomaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine
and to determine the recommended Phase 2 dose of pegaspargase
Secondary outcomes (4)
The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment
to determine the PD/PK profile and immunogenicity of pegaspargase
to determine the PK profile of gemcitabine when administered in combination with pegaspargase
and to detect preliminary evidence of tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2007
- Study completionJun 2008 (estimated)
Why it stopped: No recommended Phase II dose was determined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363610
- Sponsor's protocol ID
- EZ-002-001
- Status last verified
- May 2008
- First submitted
- 9 Aug 2006
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma
- ClinicalTrials.gov ID
- NCT00363610
- Acronym / sponsor ID
- EZ-002-001
- Keywords
- Advanced and/or Metastatic Solid Tumors and Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No recommended Phase II dose was determined.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Enzon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (estimated)
- First posted
- 15 Aug 2006 (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 study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.
Detailed description
The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc. ("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's scientific or generic name. Because it is already approved by the Food and Drug Administration (FDA), it also has a brand name - ONCASPAR®. It is approved by the FDA for the treatment of a type of leukemia (cancer of white blood cells). However, pegaspargase is not approved by the FDA for treatment of the cancer in this study. This study will research the side effects of pegaspargase when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl; its brand name is GEMZAR®. It is approved for the treatment of patients with cancer of the pancreas and of patients with breast cancer. However, gemcitabine is not approved by the FDA for treatment of any other types of cancer.
In addition, the combination of pegaspargase and gemcitabine for solid tumors and lymphoma in this study is investigational. This type of study treatment is called a "combination treatment" or a "combination study." The information (research data) from this study will be used by Enzon to plan other "combination" research studies with pegaspargase plus gemcitabine for the treatment of certain cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (15 listed)
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary treatment or there is no available standard treatment.
- Prior standard therapy was not effective, or no known therapy will extend survival or provide benefit.
- Measurable or evaluable disease.
- Age 18 years or older.
Key exclusion criteria (10 listed)
- Subjects meeting any of the following exclusion criteria will not be eligible for enrollment.
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.
- Has a coagulopathy or a history of coagulopathy.
- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
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 |
|---|---|---|
| Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma | Drug | – |
Primary outcome
The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine
and to determine the recommended Phase 2 dose of pegaspargase
4 secondary outcomes
The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment
to determine the PD/PK profile and immunogenicity of pegaspargase
to determine the PK profile of gemcitabine when administered in combination with pegaspargase
and to detect preliminary evidence of tumor
Results and safety
The study was stopped early (reason given: No recommended Phase II dose was determined.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
Related trials for Tumors
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Bladder Cancer, TURBT
RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Gastrointestinal Cancers
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma in people with Tumors and Lymphoma, run by Enzon 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 15 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: stopped early, as of the sponsor's last update on 20 May 2008. 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 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 was stopped early (reason given: No recommended Phase II dose was determined.). Results are not available in the source record.
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?
The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine. The study lists 2 primary outcomes in all. 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 20 May 2008.