Trial · NCT02034981
Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1
NCT02034981, Phase 2, Completed, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1. Trials, record NCT02034981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02034981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1
- NCT number
- NCT02034981
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Hematologic Cancers, Solid Tumors, Metastatic Cancer
- Interventions
- Crizotinib
- First posted
- 2014-01-14
- Last updated
- 2024-02-28
- Other registries' IDs
- eudract:2013-000885-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target. | Determined after 8 weeks (2 cycles) of treatment | Anti-tumor activity of crizotinib, as the primary objective of the trial, will be carried out by the determination of the objective response assessed in each cohort defined by a pathology associated with a crizotinib target alteration. The objective response is defined as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The objective response after 2 cycles (8 weeks) will be reported to define a success in the 2-stage design. |
| Secondary | The safety profile of crizotinib. | Safety profile will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart | Toxicities will be assessed by clinical and paraclinical examinations at every scheduled visit during the whole treatment period and the post-treatment follow-up period (around 2.5 years) This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting. |
| Secondary | Disease control rate | After 8 weeks (2 cycles) and 16 weeks (4 cycles) of treatment | Disease Control Rate will be the percentage of patients with a CR, PR or Stable Disease (SD) according to RECIST at the end of cycle 2 (8 weeks) and at the end of cycle 4 (16 weeks) in the group of patients evaluable for response |
| Secondary | response duration | interval between the objective response (CR or PR) and time of progression, recurrence or death | Response duration will be the time interval between the date that the criteria of CR/PR (whichever is first recorded) are met for the first time and the first date of documented re-appearance of the disease (recurrence, progression or death). If neither event has been observed, then the patient is censored at the date of the last follow up examination. |
| Secondary | Progression-free survival | from registration until time of disease progression or death | Progression-free survival will be the time interval between the date of registration and the day of first documented sign of disease progression (first day when RECIST criteria of progression are met) or day of death whatever the cause (events). If neither event has been observed, then the patient is censored at the date of the last follow up examination. |
| Secondary | Overall survival | from registration until date of death | Overall survival will be the time interval between the date of registration and the date of death, whatever the cause of death. Patients still alive at follow-up are censored at the date of last follow up. |
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT02034981
GET https://conductscience.org/api/trials/v1/NCT02034981/registered