A study of Denosumab in patients with cancer spread to the bone
- Conditions
- Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow
- Registration Number
- CTRI/2019/01/017364
- Lead Sponsor
- Intas Pharmaceuticals Ltd Biopharma Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Adults with greater than or equal to 18 years.
2. Histological or Cytological confirmation of
a. Breast adenocarcinoma or
b. Prostate cancer or
c. Non-small cell lung cancer.
3. Radiographic evidence of at least 1 bone metastasis (Confirmed by X-ray, computed
tomography, magnetic resonance imaging or bone scan).
4. Eastern Cooperative Oncology Group performance status less than or equal to 2.
5. Willing to provide written informed consent and comply with protocol requirements.
6. Able to communicate well with the investigator, to understand and comply with the
requirements of the study.
7. Patients of child bearing potential must agree to use acceptable methods of
contraception (as per investigator discretion) during the study. Female patients of child bearing potential must agree to use contraceptive methods for at least 5 months
after the last dose of the drug.
1. History of hypersensitivity to denosumab or prior use of denosumab.
2. Any of the following oral/dental conditions:
a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
b. Active dental or jaw condition which requires oral surgery.
c. Planned invasive dental procedure.
d. Non-healed dental or oral surgery.
3. Administration of intravenous (IV) bisphosphonates, fluoride, or strontium for
osteoporosis within the last 1 year or oral bisphosphonates treatment for osteoporosis in last 3 months.
4. Currently enrolled in or has not yet completed at least 30 days (or 5 half-lives,
whichever is longer) since ending earlier investigational device or drug trial(s), or patient is receiving another investigational agent(s).
5. Planned bone surgery or radiation to the bone.
6. Life expectancy less than 6 months.
7. Serum calcium levels less than or equal to 8 mg per dl.
8. Estimated creatinine clearance less than or equal to 30 ml per min.
9. Females with a positive pregnancy test at screening or lactating females
10. Tested positive for HIV, HCV or HBsAg or known to be tested positive.
11. Uncontrolled hypertension (Blood pressure more than 140 by 90 mm of Hg) (Patient on stable antihypertensive medication for more than 3 months with controlled hypertension will be eligible)
12. Any other significant medical condition which in the opinion of the investigator
increases the safety risk if patient participate in the trial
13. Clinically relevant ECG abnormality that affects the successful completion of patient treatment in the trial as per investigator.
14. Recent history (within the past 1 year) of Myocardial infarction or cerebral stroke
or patients with NYHA III or IV heart failure
15. History of drug or alcohol abuse within the 12 months prior to dosing
16. Any of the following abnormal investigational values
a. General: Any laboratory abnormality which, in the opinion of the Investigator, would prevent the patient from safely completing the study or interfere with the interpretation of the study results.
b. Liver transaminases:
i. AST or SGOT greater than or equal to 2.0 x upper limits of normal ULN
ii. ALT or SGPT greater than or equal to 2.0 x ULN
iii. Alkaline phosphatase and bilirubin greater than or equal to 1.5 x
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method