A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

NCT00629876 | Terminated Phase 1

• 2 other identifiers: HEM_101U1111-1126-1765
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anemia

Keywords

Chemotherapy; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose.

  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.

  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.

  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.

  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.

  From Day 29 to End of Treatment for every cycle.

• Change from Baseline in Hemoglobin.

  At Each Visit for every cycle.

Study Arms (1)

Peginesatide

EXPERIMENTAL

Drug: Peginesatide

Interventions

Peginesatide DRUG

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.

Also known as: Hematide

Peginesatide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead
• Affymax: collaborator

Study Sites (2)

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Corpus Christi, Texas, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Vice President Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 6, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 1, 2011

Record last verified: 2011-11

Locations

US (2)