Trial · NCT00858377
A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
NCT00858377, Phase 1, Completed, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors. Trials, record NCT00858377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
- NCT number
- NCT00858377
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 95 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Solid Tumors, Tumors
- Interventions
- Arm 1- Dose Escalation, Arm 1- Dose Expansion
- First posted
- 2009-03-09
- Last updated
- 2019-05-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests | 1 year | |
| Primary | PK profile: AMG 900 PK parameters including, but not limited to, maximum observed concentration (Cmax), minimum observed concentration, area under the plasma concentration-time curve and, if feasible, half-life | 1 year | |
| Primary | Change in levels of p-Histone H3 from baseline (part 1 - dose escalation only) | 1 year | |
| Primary | Response rate in each taxane-resistant tumor type assessed per RECIST guidelines (part 2 - dose expansion only) | 1 year | |
| Secondary | Change in tumor volume from baseline measured by volumetric CT or MRI | 1 year | |
| Secondary | Tumor response measured by CT or MRI and assessed per RECIST guidelines | 1 year | |
| Secondary | Change from baseline in maximum standardized uptake value (SUVmax) using 18FLT-PET/CT (part 2 - dose expansion only) | 1 year |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29980894 | DERIVED |
Source PubMed
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/NCT00858377
GET https://conductscience.org/api/trials/v1/NCT00858377/registered