Trial · NCT02207504
Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer
NCT02207504, Phase 1, Completed, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer. Trials, record NCT02207504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer
- NCT number
- NCT02207504
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Castration-resistant Prostate Cancer
- Interventions
- Crizotinib, Enzalutamide
- First posted
- 2014-08-04
- Last updated
- 2022-01-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of dose limiting toxicity (DLT) | 28 Days | Rate of dose limiting toxicity (DLT) in the first 28 days of study therapy by dose level when escalating doses of crizotinib are combined with enzalutamide and when appropriate a GnRH agonist. |
| Secondary | Pharmacokinetics profiles of crizotinib and enzalutamide when used in combination | C1D1, C2D1: baseline, 0.5, 1, 2, 4, 6, and 8 hours after dose; prior to dose on C1D2, C2D2, C1D15, C2D15 , C3D1 | Pharmacokinetic parameters will be determined using noncompartmental methods with WinNonLin version 5.2. Maximum blood concentration (Cmax) and time of maximum blood concentration (tmax) will be determined by visual inspection. The area under the blood concentration-time curve (linear trapezoidal rule) will be determined between 0-24 hours (AUC0-24)/. The mean (+/- STDEM) concentration-time profiles of both crizotinib and enzalutamide will be presented for each dose. |
| Secondary | The number of patients who experience adverse events and laboratory abnormalities | 2 Years | The tolerability of the combination as defined as toxicity that results in study drug discontinuation or dose reduction that would not have been mandated by the protocol such as a DLT |
| Other | Time to radiologic disease progression | 2 years | Time to radiographic progression based on the Kaplan-Meier Method from study entry to documented disease progression. |
| Other | Blood markers of bone turnover and changes in bone microenvironment | 2 years | Change in serum and bone-specific alkaline phosphatase and change in serum C-terminal telopeptides (CTx) |
| Other | Change in quantity and gene expression of CTCs | 2 years | Assessment of DNA alterations through whole exome sequencing and RNA analysis to assess the ability to detect the AR-V7 transcriptional variant and individual markers of AR and MET signaling using PCR-based methods |
| Other | Time to disease progression including PSA | 2 years | Time to radiographic progression based on the Kaplan-Meier Method from study entry to documented disease progression but with PSA values at corresponding timepoints. |
| Other | Progression-free survival | 2 years | Time to progression free survival based on the Kaplan-Meier Method from study entry to documented disease progression. |
| Other | Time to treatment failure | 2 yrs | Time to treatment failure from adverse event or progression |
| Other | PSA response in patients who remain on therapy at 12 weeks | 2 yrs | PSA response; change in alkaline phosphatase, CTx, and CTCs will be summarized descriptively |
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.
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/NCT02207504
GET https://conductscience.org/api/trials/v1/NCT02207504/registered