AnemiaPhase 1NCT00629876
A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.
A Phase 1 study testing Peginesatide in people with Anemia, run by Takeda at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia
- What is being tested?
- Peginesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Individuals with one of the following histologically confirmed tumors:
- stage IIIB/IV non-small-cell lung cancer
- metastatic breast cancer
- androgen insensitive prostate cancer and are scheduled to receive at least 4 weeks of chemotherapy, including a taxane.
- Has progression or relapse after treatment with at least one regimen of chemotherapy or hormone therapy.
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- Has a hemoglobin value of greater than or equal to 8 and less than 10.5 g/dL within 1 week prior to administration of study drug.
- Has an Eastern Cooperative Oncology Group Performance Status of 0-2.
- Has one ferritin level greater than or equal to 100 ng/mL within 4 weeks prior to study drug administration.
- Has one serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration.
- Has one vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration.
- Has one absolute neutrophil count greater than or equal to 1.5 x 109/L within 1 week prior to administration of study drug.
- The subject has a serum creatinine less than or equal to 1.5 mg/dL or a measured creatinine clearance greater than 60 mL/min.
- The subject has one platelet count greater than or equal to 100 x 109/L within 1 week prior to administration of study drug.
- The subject has a Life expectancy greater than 4 months.
- The subject has a body mass index between 18 and 30 kg/m2, inclusive, prior to study drug administration.
- The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening.
Who cannot join
- Has a history of failure to respond to erythropoiesis-stimulating agent treatment.
- Has had treatment with any erythropoiesis-stimulating agent in the past 4 weeks.
- Is known to have antibodies to other erythropoiesis-stimulating agents or history of Pure Red Cell Aplasia.
- Has received Peginesatide in a previous clinical study or as a therapeutic agent.
- Has a history of hypersensitivity or allergies to Peginesatide, other erythropoiesis-stimulating agents or related compounds.
- Has had red blood cell transfusion within 4 weeks prior to study drug administration.
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- Has known hemoglobinopathy (eg, homozygous sickle-cell disease, thalassemia of all types, etc).
- Has known hemolytic condition.
- Has known blood loss as a cause of anemia, iron deficiency anemia, or anemia caused by gastrointestinal bleeding.
- Has any previous or planned radiotherapy to more than 30% of active bone marrow.
- Has donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
- Has known intolerance to parenteral iron supplementation.
- Has received IV iron within 1 week of study drug administration.
- Has history of bone marrow or peripheral blood cell transplantation.
- Has central nervous system metastases.
- Has a history of deep venous thrombosis, pulmonary embolism or other thrombotic event (eg, stroke, myocardial infarction, etc.) in the previous 6 months or known history of hypercoagulable disorder.
- Has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc).
- Has poorly controlled hypertension per the investigator's judgment within 4 weeks prior to study drug administration (eg, systolic greater than or equal to 170 mm Hg or diastolic greater than or equal to 100 mm Hg on repeat readings).
- Has had a seizure in the 6 months prior to study drug administration.
- Has advanced chronic congestive heart failure - New York Heart Association Class III or IV.
- Has a history or presence of an abnormal electrocardiogram at Screening that, in the investigator's opinion, is clinically significant.
- Has a known history of human immunodeficiency virus.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year prior to Baseline.
- Has aspartate aminotransferase or alanine aminotransferase greater than 2.5 times the upper limit of normal (aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal if liver metastases are present), active liver disease or jaundice.
- Is currently taking or anticipated to require anticoagulants other than aspirin (eg, coumadin, ticlopidine, etc.).
- Has a bilirubin greater than the upper limit of normal.
- Has pyrexia/fever greater than or equal to 39°C within 48 hours prior to study drug administration.
- Has high likelihood of early withdrawal or interruption of the study (eg, myocardial infarction within the past 3 months, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, or any other clinically significant medical diseases or conditions within the prior 6 months that may, in the investigator's opinion, interfere with assessment or follow-up of the subject).
- Has anticipated elective surgery during the study period.
- Has exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Corpus Christi, Texas
Study site
Jacksonville, Florida
About this study
Official title: A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy
The purpose of this study is to determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy.
Read the detailed description
Currently approved erythropoiesis stimulating agents have been used successfully to increase hemoglobin levels, reduce fatigue and other anemia-related symptoms, improve daily function, and alleviate the need for transfusions of red blood cells in subjects with chronic kidney disease-related anemia or in cancer subjects with chemotherapy-induced anemia.
Peginesatide (hematide) Injection is a parenteral formulation for administration by intravenous or subcutaneous injection that is being developed for the correction of anemia in patients with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of patients with anemia due to concomitantly administered chemotherapy.
This is a multicenter, open-label dose escalation study to evaluate the safety, tolerability, and efficacy of multiple doses of peginesatide Injection in subjects with refractory non-small cell lung cancer, breast cancer, or prostate cancer. These subjects must have anemia diagnosed as a result of taxane chemotherapy.
- Conditions
- Anemia
- Being tested
- Peginesatide
- Keywords
- Chemotherapy, Drug Therapy
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeginesatideDrug
Also called Hematide
Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles.
Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| Peginesatide | Experimental | Not described Receives: Drug: Peginesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose.
Measured: End of Treatment.
Secondary outcomes (15)
Proportion of subjects who have 2 consecutive Hgb values of either an increase of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
Measured: At All Visits for every cycle.
Proportion of subjects who have an increase in Hgb of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
Measured: Days 22 and 43 for every cycle.
Proportion of subjects with 2 consecutive Hgb values increase of ≥1 g/dL or ≥11 g/dL during the Treatment phase absent of red blood cell transfusion within the prior 28 days and without excursion of Hgb values above 12 g/dL for ≥2 consecutive weeks.
Measured: Within the prior 28 days of every cycle for a minimum of 2 consecutive weeks.
Proportion of subjects who received at least 1 RBC transfusion.
Measured: From Day 29 to End of Treatment for every cycle.
Change from Baseline in Hemoglobin.
Measured: At Each Visit for every cycle.
Duration of maintaining Hgb values within the range of 10.5 g/dL and 12.0 g/dL.
Measured: At Each Visit for every cycle.
Pharmacokinetics of Peginesatide (PK Cohort Only).
Measured: At Each Visit for every cycle.
Adverse events and serious adverse events.
Measured: At All Visits for every cycle.
Physical examination (including weight, vital signs, and oral temperature).
Measured: At All Visits for every cycle.
Clinical Laboratory Tests and Electrocardiograms.
Measured: At All Visits for every cycle.
Electrocardiograms.
Measured: At Final Visit for every cycle.
Signs and symptoms for thromboembolytic events.
Measured: At All Visits for every cycle.
Proportion of subjects who have incidence of Hgb values >12 g/dL.
Measured: At All Visits for every cycle.
Proportion of subjects who have Hgb increases by more than 1 g/dL in a 2-week period.
Measured: At All Visits for every cycle.
Tumor progression.
Measured: Every 2 cycles of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Due to the uncertain regulatory landscape for erythropoiesis-stimulating agents in oncology indications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affymax
- Responsible party
- Sponsor
- Investigators
- Vice President Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629876
- Sponsor's protocol ID
- HEM_101
- Other IDs
- U1111-1126-1765
- Status last verified
- Nov 2011
- First submitted
- 26 Feb 2008
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT00629876
- Acronym / sponsor ID
- HEM_101
- Conditions
- Anemia
- Keywords
- Chemotherapy, Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the uncertain regulatory landscape for erythropoiesis-stimulating agents in oncology indications.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Affymax
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Mar 2008 (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 determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy.
Detailed description
Currently approved erythropoiesis stimulating agents have been used successfully to increase hemoglobin levels, reduce fatigue and other anemia-related symptoms, improve daily function, and alleviate the need for transfusions of red blood cells in subjects with chronic kidney disease-related anemia or in cancer subjects with chemotherapy-induced anemia.
Peginesatide (hematide) Injection is a parenteral formulation for administration by intravenous or subcutaneous injection that is being developed for the correction of anemia in patients with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of patients with anemia due to concomitantly administered chemotherapy.
This is a multicenter, open-label dose escalation study to evaluate the safety, tolerability, and efficacy of multiple doses of peginesatide Injection in subjects with refractory non-small cell lung cancer, breast cancer, or prostate cancer. These subjects must have anemia diagnosed as a result of taxane chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginesatide | Experimental | Drug: Peginesatide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Individuals with one of the following histologically confirmed tumors:
- Has progression or relapse after treatment with at least one regimen of chemotherapy or hormone therapy.
- Has a hemoglobin value of greater than or equal to 8 and less than 10.5 g/dL within 1 week prior to administration of study drug.
- Has an Eastern Cooperative Oncology Group Performance Status of 0-2.
Key exclusion criteria (30 listed)
- Has a history of failure to respond to erythropoiesis-stimulating agent treatment.
- Has had treatment with any erythropoiesis-stimulating agent in the past 4 weeks.
- Is known to have antibodies to other erythropoiesis-stimulating agents or history of Pure Red Cell Aplasia.
- Has received Peginesatide in a previous clinical study or as a therapeutic agent.
- Has a history of hypersensitivity or allergies to Peginesatide, other erythropoiesis-stimulating agents or related compounds.
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 |
|---|---|---|
| PeginesatideAlso: HematidePeginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles. Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen. | Drug | Peginesatide |
Primary outcome
Maximum tolerated dose.
Time frame: End of Treatment.
15 secondary outcomes
Proportion of subjects who have 2 consecutive Hgb values of either an increase of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
Time frame: At All Visits for every cycle.
Proportion of subjects who have an increase in Hgb of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
Time frame: Days 22 and 43 for every cycle.
Proportion of subjects with 2 consecutive Hgb values increase of ≥1 g/dL or ≥11 g/dL during the Treatment phase absent of red blood cell transfusion within the prior 28 days and without excursion of Hgb values above 12 g/dL for ≥2 consecutive weeks.
Time frame: Within the prior 28 days of every cycle for a minimum of 2 consecutive weeks.
Proportion of subjects who received at least 1 RBC transfusion.
Time frame: From Day 29 to End of Treatment for every cycle.
Change from Baseline in Hemoglobin.
Time frame: At Each Visit for every cycle.
Duration of maintaining Hgb values within the range of 10.5 g/dL and 12.0 g/dL.
Time frame: At Each Visit for every cycle.
Pharmacokinetics of Peginesatide (PK Cohort Only).
Time frame: At Each Visit for every cycle.
Adverse events and serious adverse events.
Time frame: At All Visits for every cycle.
Physical examination (including weight, vital signs, and oral temperature).
Time frame: At All Visits for every cycle.
Clinical Laboratory Tests and Electrocardiograms.
Time frame: At All Visits for every cycle.
Electrocardiograms.
Time frame: At Final Visit for every cycle.
Signs and symptoms for thromboembolytic events.
Time frame: At All Visits for every cycle.
Proportion of subjects who have incidence of Hgb values >12 g/dL.
Time frame: At All Visits for every cycle.
Proportion of subjects who have Hgb increases by more than 1 g/dL in a 2-week period.
Time frame: At All Visits for every cycle.
Tumor progression.
Time frame: Every 2 cycles of chemotherapy.
Results and safety
The study was stopped early (reason given: Due to the uncertain regulatory landscape for erythropoiesis-stimulating agents in oncology indications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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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.
Vice President Clinical Science study director
Takeda
2 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 Peginesatide in people with Anemia, run by Takeda at 2 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 17 inclusion and 30 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: Due to the uncertain regulatory landscape for erythropoiesis-stimulating agents in oncology indications.). 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?
Maximum tolerated dose. (time frame: End of Treatment.). 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 1 Dec 2011.