Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

NCT00425204 | Completed Phase 2

• 2 other identifiers: 20020375Abgenix Protocol No. ABX-0311
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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  Until disease progression, an AE or withdrawn consent

Secondary Outcomes (1)

• 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  Until disease progression, an AE or withdrawn consent

Study Arms (1)

Open Label

EXPERIMENTAL

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.

Drug: Panitumumab (ABX-EGF)

Interventions

Panitumumab (ABX-EGF) DRUG

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.

Open Label

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: March 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: March 1, 2008
• Last Updated: September 15, 2008

Record last verified: 2008-09