MDACC Study Summary 2006-0481 (Archived)

Study Summary
No. 2006-0481:.......Advanced Cancers......Saroj Vadhan-Raj......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2006-0481

Study Title:	A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Approximately every 4 weeks.

Treatment Agents:	Denosumab Zometa	Home Care:	Supportive care as needed

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this extension phase of the clinical research study is to give you an opportunity to continue treatment with denosumab on the 1 time every 4 weeks study visit schedule.

Study Objectives / Outcomes

Primary
1. To determine if denosumab is non-inferior to zoledronic acid (Zometa.) with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression

Secondary
1. To determine if denosumab is superior to zoledronic acid with respect to the first on-study SRE
2. To determine if denosumab is superior to zoledronic acid with respect to the first-and-subsequent on-study SRE (multiple event analysis)
3. To assess the safety and tolerability of denosumab compared with zoledronic acid

Exploratory
1. To compare the treatment effect of denosumab with zoledronic acid on the first on-study occurrence of an SRE or hypercalcemia of malignancy (HCM)
2. To compare the treatment effect of denosumab with zoledronic acid on the first on-study use of radiation to bone
3. To compare the treatment effect of denosumab with zoledronic acid on analgesic use
4. To evaluate the treatment effects of denosumab and zoledronic acid on other clinical outcomes (ie, overall survival, progression of disease in bone, and overall progression of disease)
5. To evaluate the proportions of subjects who have a documented SRE by 49 wks and by the primary analysis data cut off date.
6. To compare the treatment effect of denosumab with zoledronic acid on pain
7. To evaluate treatment effects on healthcare utilization and patient reported outcomes (PROs) including scales from the Brief Pain Inventory-Short Form (BPI-SF) (pain severity and pain interference), scales from the Functional Assessment of Cancer Therapy-General (FACT-G), (total score, physical well being, functional well being, social/family well being, and emotional well being) and utility score from the EuroQol-5 Dimensions (EQ-5D)
9. To measure serum (trough) concentrations of denosumab.
10. Percent change in bone turnover markers (BTM).

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/05/2006

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	1690

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Adult with histologically or cytologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma

2) Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis (or lytic bone lesion from multiple myeloma)

3) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

4) Adequate organ function as defined by the following criteria: 1) Serum aspartate aminotransferase (AST) </= 5 x upper limit of normal (ULN); serum alanine aminotransferase (ALT) </= 5 x ULN; Serum total bilirubin </= 2 x ULN; Creatinine clearance >/= 30 mL/min; Albumin-adjusted serum calcium >/= 2.0 mmol/L (8.0 mg/dL) and </= 2.9 mmol/L (11.5 mg/dL). Albumin-adjusted serum calcium, if applicable, will be calculated by the central laboratory.

5) Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.

Exclusion Criteria:

1) Diagnosis of breast or prostate cancer

2) Current or prior IV bisphosphonate administration

3) Current or prior oral bisphosphonate for the treatment of bone metastasis / osteolytic lesion

4) Planned radiation therapy or surgery to bone

5) Prior administration of denosumab

6) Known brain metastases

7) Life expectancy less than 6 months

8) Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw. In addition, patients that can not provide documentation of their dental history/evaluation for the past year and/or refuse a dental exam prior to study entry will be excluded.

9) Active dental or jaw condition which requires oral surgery

10) Non-healed dental/oral surgery

11) Planned invasive dental procedure over the course of the study

12) Evidence of any of the following conditions per subject self report or medical chart review: 1) Any other prior malignancy (other than basal cell carcinoma, or in situ cervical cancer) with active disease within 3 years before randomization 2) Known infection with human immunodeficiency virus (since there may be an increased risk of infection for this group of participants) 3) Active infection with Hepatitis B or Hepatitis C virus

13) Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results

14) Thirty days or less since receiving an investigational product or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical trial

15) Pregnant or breast-feeding women

16) Subject with reproductive potential who will not agree to use effective contraception (as defined by the principal investigator or designee)

17) Known sensitivity to any of the products to be administered during the study (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)

Links

Registration Number: NCT00330759
Study Information on Clinical Trials Registry (clinicaltrials.gov)