Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

Prostate Cancer Clinical Trial

Official title:

A Multi-Center, Open-Label Clinical Trial To Determine The Safety of ABX-EGF As Continued Treatment For Patients Who Have Benefited From and Tolerated Prior ABX-EGF Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425204
• Other study ID #: 20020375
• Secondary ID: Abgenix Protocol
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2007
• Last updated: September 11, 2008
• Start date: March 2004
• Est. completion date: March 2008

Study information

• Verified date: September 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment

Other known NCT identifiers

• NCT00081185

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to comprehend and sign an IRB approved Informed Consent Form

• Male or female 18 years of age or older

• Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study

• Previously received and tolerated panitumumab treatment on studies 20020374 Part 2 or 20030138/20040116

• Is considered "stable" or "responding" based on the RECIST (20020374 Part 2) or WHO (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study

• No more than 2 months (60 days) have elapsed since the final treatment visit of the previous panitumumab clinical trial

• Karnofsky score > or = 70%

Exclusion Criteria:

• Brain metastases (20040116 patients are allowed only if controlled and asymptomatic)

• Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). Exception: Patients in the Motzer Intermediate Risk Group from 20020374 Cohort 2 with uncontrolled high corrected calcium (>10 mg/dl) may be enrolled

• Use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study

• Prior treatment with another anti-EGFr agent, other than panitumumab

• Myocardial infarction within 1 year prior to entering the study

• Has other cancer that has been active and required treatment within the past 5 years (basal cell carcinoma or cervical carcinoma in situ are allowed)

• Pregnant or breast feeding female; female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 6 months following treatment

• Male patient unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment

• Known to be HIV positive

• History of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risks associated with study drug administration

• Allergy to the ingredients of the study medication or to Staphylococcus Protein A

• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Colorectal Cancer
• Non-Small Cell Lung Cancer
• Prostate Cancer
• Solid Tumors

Intervention

Drug:
• Panitumumab (ABX-EGF)
Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide continued, extended panitumumab treatment to subjects who appeared to have benefited from and tolerated previous panitumumab treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116		Until disease progression, an AE or withdrawn consent	Yes
Secondary	To assess the safety of multidose administration of panitumumab in subjects who received continued and extended panitumumab treatment		Until disease progression, an AE or withdrawn consent	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling