A Phase 2 interventional study of denosumab in Breast Cancer, Hypercalcemia of Malignancy and Colon Cancer, sponsored by Amgen. Completed at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 33 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
Drug: denosumab
120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.
Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
Time frame: 10 days
Percentage of Participants With a Response by Visit
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
Time frame: Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Percentage of Participants With a Complete Response by Visit
Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\])).
Time frame: Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Time to Response
Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1. Time to response was analyzed using Kaplan-Meier methods.
Time frame: From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Time to Complete Response
Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan-Meier methods.
Time frame: From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Duration of Response
Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached \> 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.
Time frame: From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Duration of Complete Response
Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached \> 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.
Time frame: From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Time to Relapse/Nonresponse of Hypercalcemia of Malignancy
Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached \> 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.
Time frame: From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Change From Baseline in Corrected Serum Calcium
Time frame: Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
First patient was enrolled on 16 November 2009 and the last patient enrolled on 02 July 2012. Data are reported as of the primary analysis cut-off date of 13 September 2012.
| Milestone | Denosumab |
|---|---|
| Started | 33 |
| Completed | 0 |
| Not completed | 33 |
| Withdrew: Death | 10 |
| Withdrew: Adverse event | 8 |
| Withdrew: Disease progression | 5 |
| Withdrew: Other | 4 |
| Withdrew: Requirement for alternative therapy | 3 |
| Withdrew: Ongoing in study | 2 |
| Withdrew: Withdrawal by subject | 1 |
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
| percentage of participants | Denosumab |
|---|---|
| Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab | 63.6 (45.1 to 79.6) |
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
| percentage of participants | Denosumab |
|---|---|
| By Day 2 | 9.1 (1.9 to 24.3) |
| By Day 4 | 24.2 (11.1 to 42.3) |
| By Day 8 | 48.5 (30.8 to 66.5) |
| By Day 10 | 63.6 (45.1 to 79.6) |
| By Day 15 | 63.6 (45.1 to 79.6) |
| By Day 19 | 69.7 (51.3 to 84.4) |
| By Day 23 | 69.7 (51.3 to 84.4) |
| By Day 29 | 69.7 (51.3 to 84.4) |
| By Day 36 | 69.7 (51.3 to 84.4) |
| By Day 43 | 69.7 (51.3 to 84.4) |
| By Day 50 | 69.7 (51.3 to 84.4) |
| By Day 57 | 69.7 (51.3 to 84.4) |
Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\])).
| percentage of participants | Denosumab |
|---|---|
| By Day 2 | 3.0 (0.1 to 15.8) |
| By Day 4 | 15.2 (5.1 to 31.9) |
| By Day 8 | 27.3 (13.3 to 45.5) |
| By Day 10 | 36.4 (20.4 to 54.9) |
| By Day 15 | 45.5 (28.1 to 63.6) |
| By Day 19 | 45.5 (28.1 to 63.6) |
| By Day 23 | 51.5 (33.5 to 69.2) |
| By Day 29 | 51.5 (33.5 to 69.2) |
| By Day 36 | 60.6 (42.1 to 77.1) |
| By Day 43 | 63.6 (45.1 to 79.6) |
| By Day 50 | 63.6 (45.1 to 79.6) |
| By Day 57 | 63.6 (45.1 to 79.6) |
Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1. Time to response was analyzed using Kaplan-Meier methods.
| days | Denosumab |
|---|---|
| Time to Response | 9.0 (5.00 to 19.00) |
Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan-Meier methods.
| days | Denosumab |
|---|---|
| Time to Complete Response | 23.0 (11.00 to 43.00) |
Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached \> 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.
| days | Denosumab |
|---|---|
| Duration of Response | 104.0 (9.00 to NA) |
Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached \> 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.
| days | Denosumab |
|---|---|
| Duration of Complete Response | 34.0 (1.00 to 134.00) |
Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached \> 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.
| days | Denosumab |
|---|---|
| Time to Relapse/Nonresponse of Hypercalcemia of Malignancy | 19.0 (5.00 to 114.00) |
| mmol/L | Denosumab |
|---|---|
| Change from Baseline to Day 2 (n = 32) | -0.13 (-0.31 to 0.09) |
| Change from Baseline to Day 4 (n = 32) | -0.25 (-0.44 to -0.14) |
| Change form Baseline to Day 8 (n = 27) | -0.43 (-0.73 to -0.20) |
| Change from Baseline to Day 10 (n = 28) | -0.54 (-0.77 to -0.25) |
| Change from Baseline to Day 15 (n = 24) | -0.51 (-0.89 to -0.15) |
| Change from Baseline to Day 19 (n = 22) | -0.64 (-0.80 to -0.30) |
| Change from Baseline to Day 23 (n = 21) | -0.60 (-0.85 to -0.40) |
| Change from Baseline to Day 29 (n = 22) | -0.53 (-0.75 to -0.30) |
| Change from Baseline to Day 36 (n = 20) | -0.61 (-0.84 to -0.15) |
| Change from Baseline to Day 43 (n = 19) | -0.75 (-0.98 to -0.10) |
| Change from Baseline to Day 50 (n = 15) | -0.83 (-1.03 to -0.20) |
| Change from Baseline to Day 57 (n = 17) | -0.73 (-1.03 to -0.25) |
Collected over Median time on study was 1.8 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Denosumab 120 mg Q4W | — | 29/33 (87.9%) | 26/33 (78.8%) |
| Event | Denosumab 120 mg Q4W |
|---|---|
| HypercalcaemiaMetabolism and nutrition disorders | 5/33 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/33 |
| TachycardiaCardiac disorders | 2/33 |
| DiarrhoeaGastrointestinal disorders | 2/33 |
| Head and neck cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/33 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/33 |
| Multiple myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/33 |
| Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/33 |
| AnaemiaBlood and lymphatic system disorders | 1/33 |
| PancytopeniaBlood and lymphatic system disorders | 1/33 |
| Event | Denosumab 120 mg Q4W |
|---|---|
| NauseaGastrointestinal disorders | 10/33 |
| Oedema peripheralGeneral disorders | 8/33 |
| HeadacheNervous system disorders | 8/33 |
| ConstipationGastrointestinal disorders | 7/33 |
| DiarrhoeaGastrointestinal disorders | 7/33 |
| VomitingGastrointestinal disorders | 7/33 |
| Decreased appetiteMetabolism and nutrition disorders | 7/33 |
| FatigueGeneral disorders | 6/33 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/33 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/33 |
| Age, Continuous(years) | Denosumab |
|---|---|
| Mean | 60.3 ± 14.8 |
| Sex: Female, Male(Participants) | Denosumab |
|---|---|
| Female | 12 |
| Male | 21 |
| Race/Ethnicity, Customized(participants) | Denosumab |
|---|---|
| White or Caucasian | 23 |
| Black or African American | 7 |
| Hispanic or Latino | 1 |
| Asian | 1 |
| Other | 1 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(participants) | Denosumab |
|---|---|
| 0 | 1 |
| 1 | 7 |
| 2 | 14 |
| 3 | 8 |
| 4 | 3 |
| Primary Tumor Type(participants) | Denosumab |
|---|---|
| Bladder | 1 |
| Breast | 6 |
| Head and neck | 2 |
| Liver | 1 |
| Neuroendocrine/carcinoid | 4 |
| Non-hodgkin's | 2 |
| Non-small cell lung cancer | 3 |
| Ovarian | 1 |
| Renal | 3 |
| Small cell lung cancer | 1 |
| Soft tissue sarcoma | 1 |
| Unknown (primary tumor) | 1 |
| Multiple myeloma | 3 |
| Chronic lymphocytic leukemia | 2 |
| IGG kappa multiple myeloma | 1 |
| Myeloma | 1 |
| Time from initial cancer diagnosis to enrollment(months) | Denosumab |
|---|---|
| Mean | 56.9 ± 68.8 |
| Presence of metastatic disease at enrollment(participants) | Denosumab |
|---|---|
| Yes | 30 |
| No | 3 |
| Presence of bone metastatic disease at enrollment(participants) | Denosumab |
|---|---|
| Yes | 13 |
| No | 20 |
2 further baseline measures are reported on the registry.
Ran from Nov 2009 to primary completion in Sep 2012, 33 months.
Results were first posted in Jan 2015, 2 years 3 months after primary completion. A results delay was requested in May 2014.
Of 232 industry-sponsored phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 53. This study's 33 months is close to that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Denosumab