Trial · NCT00629343

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

NCT00629343, Phase 1, Completed, Columbia University; results first posted 2025-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide. Trials, record NCT00629343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00629343

On this page

Trial

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

Title: Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
NCT number: NCT00629343
Status: Completed
Phases: Phase 1
Enrollment: 27 participants, actual
Lead sponsor: Columbia University
Conditions: Soft Tissue Sarcoma, Mesothelioma
Interventions: Azacitidine, Temozolomide
First posted: 2008-03-06
Last updated: 2025-06-05
Results first posted: 2025-06-05

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose of Temozolomide	Up to 26 weeks for each dosing cohort	Maximum tolerated dose of temozolomide when used in combination with azacitidine
Primary	Maximum Tolerated Dose of Azacitidine	Up to 26 weeks for each dosing cohort	Maximum tolerated dose of azacitidine when used in combination with temozolomide

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose of Temozolomide	Up to 26 weeks for each dosing cohort		mg/m^2	NUMBER
PRIMARY	Maximum Tolerated Dose of Azacitidine	Up to 26 weeks for each dosing cohort		mg/m^2	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Maximum Tolerated Dose of Temozolomide	Treatment		200		mg/m^2
Maximum Tolerated Dose of Azacitidine	Treatment		75		mg/m^2

Source ClinicalTrials.gov

Participant flow27

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

Period	Milestone	Group	Participants
Dose Level 1: Azacitidine 25mg	STARTED	Azacitidine 25mg	3
Dose Level 1: Azacitidine 25mg	STARTED	Azacitidine 50 mg	0
Dose Level 1: Azacitidine 25mg	STARTED	Azacitidine 75 mg	0
Dose Level 1: Azacitidine 25mg	COMPLETED	Azacitidine 25mg	3
Dose Level 1: Azacitidine 25mg	COMPLETED	Azacitidine 50 mg	0
Dose Level 1: Azacitidine 25mg	COMPLETED	Azacitidine 75 mg	0
Dose Level 1: Azacitidine 25mg	NOT COMPLETED	Azacitidine 25mg	0
Dose Level 1: Azacitidine 25mg	NOT COMPLETED	Azacitidine 50 mg	0
Dose Level 1: Azacitidine 25mg	NOT COMPLETED	Azacitidine 75 mg	0
Dose Level 2: Azacitidine 50 mg	STARTED	Azacitidine 25mg	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events3

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

Type	Event	Organ system	Group	Affected	At risk
serious	Death due to progression of disease	General disorders	Azacitidine 25 mg	0	3
serious	Death due to progression of disease	General disorders	Azacitidine 50 mg	0	3
serious	Death due to progression of disease	General disorders	Azacitidine 75 mg	15	17

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Azacitidine 25 mg	0	3
Total, all-cause mortality	Azacitidine 50 mg	0	3
Total, all-cause mortality	Azacitidine 75 mg	15	17
Total, other adverse events	Azacitidine 25 mg	0	3
Total, other adverse events	Azacitidine 50 mg	0	3
Total, other adverse events	Azacitidine 75 mg	0	17
Total, serious adverse events	Azacitidine 25 mg	0	3
Total, serious adverse events	Azacitidine 50 mg	0	3
Total, serious adverse events	Azacitidine 75 mg	15	17

Source ClinicalTrials.gov

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/NCT00629343

GET https://conductscience.org/api/trials/v1/NCT00629343/flow?page=2

API reference For AI assistants