Trial · NCT01712217
A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib
NCT01712217, Phase 1, Phase 2, Completed, Astex Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib. Trials, record NCT01712217. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712217
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib
- NCT number
- NCT01712217
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 220 participants, actual
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Interventions
- AT13387, Crizotinib
- First posted
- 2012-10-23
- Last updated
- 2024-08-02
- Other registries' IDs
- eudract:2012-001575-37
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib. | 12 months | \- Number of patients with adverse events |
| Primary | Part B: The comparison of objective response rate by RECIST 1.1 between crizotinib alone and the combination of crizotinib + AT13387. | 18 months | \- Change in tumor measurements by RECIST 1.1 every 8 weeks |
| Primary | Part C: The objective overall response rate for AT13387 alone and the objective response rate (CR+PR) for AT13387 + crizotinib at Stage 1 and Stage 2 of the Simon's 2-stage design. | 18 months | \- Change in tumor measurements by RECIST 1.1 every 8 weeks |
| Secondary | Part A: Pharmacokinetics of combination treatment with AT13387 and crizotinib | 12 months | * Area under the plasma concentration versus time curve (AUC) of AT13387 and crizotinib alone and in combination Week 4 * Maximum concentration (Cmax) OF AT13387 and crizotinib alone and in combination by Week 4 |
| Secondary | Part A: Assess antitumor activity of crizotinib + AT13387 combination, circulating tumor cells (CTCs) response, progression free survival (PFS) and overall survival (OS). | 12 months | * Change in tumor measurements by RECIST 1.1 every 8 weeks * Change in CTCs from baseline every 4 weeks * Assessment of PFS and OS as measured by weeks |
| Secondary | Part B: Assess safety of AT13387 in combination with crizotinib; compare PFS and OS between crizotinib and crizotinib + AT13387; and assess overall response rate (CR + PR) in crizotinib patients who crossover to crizotinib + AT13387 | 18 months | * Number of patients with adverse events * PFS and OS as measured in weeks * Response rate as measured by RECIST 1.1 every 8 weeks |
| Secondary | Part C: Assess safety of AT13387 alone and in combination with crizotinib who progressed on crizotinib treatment; and compare the PFS and OS of AT13387 administered alone or in combination with crizotinib | 18 months | * Number of patients with adverse events * PFS and OS as measured in weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01712217
GET https://conductscience.org/api/trials/v1/NCT01712217/registered