Trial · NCT00528645
AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
NCT00528645, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer. Trials, record NCT00528645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528645
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
- NCT number
- NCT00528645
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extensive Stage Small Cell Lung Cancer, Lung Metastases, Malignant Pleural Effusion, Recurrent Small Cell Lung Cancer
- Interventions
- saracatinib
- First posted
- 2007-09-12
- Last updated
- 2017-12-07
- Results first posted
- 2014-02-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate at 12 Weeks | 12 weeks | The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline. |
| Secondary | Overall Survival | From registration to death due to any cause, assessed up to 2 years | Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) | After every other 21-day cycle, up to 2 years. | Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart.. |
| Secondary | Progression Free Survival | From registration to documentation of disease progression or death, assessed up to 2 years | Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate at 12 Weeks | 12 weeks | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | From registration to death due to any cause, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) | After every other 21-day cycle, up to 2 years. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival | From registration to documentation of disease progression or death, assessed up to 2 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate at 12 Weeks | Treatment (Saracatinib) | 26 | 95% Confidence Interval 10 to 48 | percentage of participants | |
| Overall Survival | Treatment (Saracatinib) | 7.8 | 95% Confidence Interval 6.9 to 10.6 | months | |
| Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) | Treatment (Saracatinib) | Complete Response (CR) | 0 | Participants | |
| Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) | Treatment (Saracatinib) | Partial Response (PR) | 0 | Participants | |
| Progression Free Survival | Treatment (Saracatinib) | 1.5 | 95% Confidence Interval 1.3 to 1.6 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Saracatinib) | 23 | |
| Overall Study | COMPLETED | Treatment (Saracatinib) | 20 | |
| Overall Study | NOT COMPLETED | Treatment (Saracatinib) | 3 |
Source ClinicalTrials.gov
Adverse events54
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 | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Treatment (Saracatinib) | 20 | 23 | 39 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Saracatinib) | 6 | 23 | 26 |
| other | Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Treatment (Saracatinib) | 1 | 23 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Saracatinib) | 9 | 23 | 12 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Saracatinib) | 7 | 23 | 9 |
| other | Fatigue | General disorders | Treatment (Saracatinib) | 16 | 23 | 45 |
| other | Fever | General disorders | Treatment (Saracatinib) | 1 | 23 | 1 |
| other | Hepatic failure | Hepatobiliary disorders | Treatment (Saracatinib) | 1 | 23 | 1 |
| other | Bladder infection | Infections and infestations | Treatment (Saracatinib) | 1 | 23 | 1 |
| other | Skin infection | Infections and infestations | Treatment (Saracatinib) | 1 | 23 | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Saracatinib) | ||
| Total, other adverse events | Treatment (Saracatinib) | 22 | 23 |
| Total, serious adverse events | Treatment (Saracatinib) | 6 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA025224 | North Central Cancer Treatment Group | BUCKNER, JAN C | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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.
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/NCT00528645
GET https://conductscience.org/api/trials/v1/NCT00528645/events?page=2