Open Label Extension In Cancer Patients

Completed · Phase 2

Conditions studied: Neoplasms, Bone Metastases

In brief

To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.

Key facts

Study ID

NCT00830180

Run by

Pfizer

People needed

41

Starts

2009-10-29

Expected to finish

2013-02-14

Last updated by the study team

2021-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been diagnosed as having metastasized to bone;
• Karnofsky Performance Score ≥40% at Baseline;
• patients randomized and treated with intravenous study drug in double-blind Study A4091003.

You may not qualify if…

• Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;
• Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension Study A4091029.

Where it is running

• UCSD Center for Pain Medicine — La Jolla, California, United States
• UCSD Medical Center - Thornton Hospital — La Jolla, California, United States
• UCSD Periman Ambulatory Care Center — La Jolla, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• WK River Cities Clinical Research Center — Shreveport, Louisiana, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Nuhr Zentrum — Senftenberg, Austria
• Clinic of Oncology — Banja Luka, Bosnia and Herzegovina
• General Hospital Varazdin — Varaždin, Croatia
• Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly — Székesfehérvár, Hungary
• Central India Cancer Research Institute Central India Cancer Research Institute — Nagpur, Maharashtra, India
• Shatabdi Super Speciality Hospital — Nashik, Maharashtra, India
• Chhatrapati Shahuji Maharaj Medical University — Lucknow, Uttar Pradesh, India
• Latvian Oncology Centre — Riga, Latvia
• Niepubliczny Zaklad Opieki Zdrowotnej — Bydgoszcz, Poland
• Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku — Gdansk, Poland
• **Poradnia Medycyny Paliatywnej, Hospicjum Palium — Poznan, Poland
• Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie — Poznan, Poland
• NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej — Włocławek, Poland
• Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica — Banská Bystrica, Slovakia
• Narodny onkologicky ustav — Bratislava, Slovakia
• Severance Hospital, Yonsei University College of Medicine — Seodaemun-gu, Seoul, South Korea
• Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine — Seoul, South Korea

Full record on ClinicalTrials.gov

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