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Trial · NCT01204203

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

NCT01204203, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2017-05-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901). Trials, record NCT01204203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01204203

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
NCT number
NCT01204203
Status
Completed
Phases
Phase 2
Enrollment
8 participants, actual
Lead sponsor
University of Alabama at Birmingham
Conditions
Mesothelioma
Interventions
Zometa
First posted
2010-09-17
Last updated
2017-05-24
Results first posted
2017-05-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTumor Response Rate Following Zoledronic Acid (Zometa)Baseline up to 28 months or until progressive disease or death
The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
SecondaryProgression Free Survival (PFS)Baseline up to 28 months
Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.
SecondaryOverall Survival (OS)Baseline up to 28 monthsOverall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTumor Response Rate Following Zoledronic Acid (Zometa)Baseline up to 28 months or until progressive disease or deathParticipants with advanced malignant pleural mesothelioma.percentage of respondersNUMBER
SECONDARYProgression Free Survival (PFS)Baseline up to 28 monthsParticipants with advanced malignant pleural mesothelioma.MonthsMEDIAN
SECONDARYOverall Survival (OS)Baseline up to 28 monthsParticipants with advanced malignant pleural mesothelioma.monthsMEDIAN

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Tumor Response Rate Following Zoledronic Acid (Zometa)Zometa12.5percentage of responders
Progression Free Survival (PFS)Zometa2Full Range 0.5 to 21Months
Overall Survival (OS)Zometa7Full Range 0.8 to 28months

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDZoledronic Acid (Zometa)8
Overall StudyCOMPLETEDZoledronic Acid (Zometa)8
Overall StudyNOT COMPLETEDZoledronic Acid (Zometa)0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityZoledronic Acid (Zometa)08
Total, other adverse eventsZoledronic Acid (Zometa)08
Total, serious adverse eventsZoledronic Acid (Zometa)08

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01204203

GET https://conductscience.org/api/trials/v1/NCT01204203/registered