Open Label Extension In Cancer Patients

NCT ID: NCT00830180

Last Updated: 2021-04-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-29

Study Completion Date

2013-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms Bone Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-NGF AB

Group Type EXPERIMENTAL

Anti-NGF AB

Intervention Type BIOLOGICAL

Solution for injection, 10 mg, one injection/8 weeks

Interventions

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Anti-NGF AB

Solution for injection, 10 mg, one injection/8 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCSD Center for Pain Medicine

La Jolla, California, United States

Site Status

UCSD Medical Center - Thornton Hospital

La Jolla, California, United States

Site Status

UCSD Periman Ambulatory Care Center

La Jolla, California, United States

Site Status

UCSD Moores Cancer Center

La Jolla, California, United States

Site Status

WK River Cities Clinical Research Center

Shreveport, Louisiana, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Nuhr Zentrum

Senftenberg, , Austria

Site Status

Clinic of Oncology

Banja Luka, , Bosnia and Herzegovina

Site Status

General Hospital Varazdin

Varaždin, , Croatia

Site Status

Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly

Székesfehérvár, , Hungary

Site Status

Central India Cancer Research Institute Central India Cancer Research Institute

Nagpur, Maharashtra, India

Site Status

Shatabdi Super Speciality Hospital

Nashik, Maharashtra, India

Site Status

Chhatrapati Shahuji Maharaj Medical University

Lucknow, Uttar Pradesh, India

Site Status

Latvian Oncology Centre

Riga, , Latvia

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej

Bydgoszcz, , Poland

Site Status

Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku

Gdansk, , Poland

Site Status

**Poradnia Medycyny Paliatywnej, Hospicjum Palium

Poznan, , Poland

Site Status

Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

Poznan, , Poland

Site Status

NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej

Włocławek, , Poland

Site Status

Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

Narodny onkologicky ustav

Bratislava, , Slovakia

Site Status

Severance Hospital, Yonsei University College of Medicine

Seodaemun-gu, Seoul, South Korea

Site Status

Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

Seoul, , South Korea

Site Status

Countries

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United States Austria Bosnia and Herzegovina Croatia Hungary India Latvia Poland Slovakia South Korea

References

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Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.

Reference Type DERIVED
PMID: 25919474 (View on PubMed)

Related Links

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Other Identifiers

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2008-005182-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CANCER PAIN OL EXTENSION

Identifier Type: OTHER

Identifier Source: secondary_id

A4091029

Identifier Type: -

Identifier Source: org_study_id

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