Trial · NCT01987362
A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies
NCT01987362, Phase 1, Completed, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies. Trials, record NCT01987362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01987362
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies
- NCT number
- NCT01987362
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Solid Tumors, Advanced Solid Tumors
- Interventions
- RO6870810
- First posted
- 2013-11-19
- Last updated
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with DLTs | Day 1 up to Day 28 (or Day 21) | |
| Primary | MTD of RO6870810 | Day 1 up to Day 28 (or Day 21) | |
| Primary | Percentage of Participants with Adverse Events | Baseline up to approximately 47 months | |
| Secondary | Area Under the Concentration Versus Time Curve from Time 0 (Pre-dose) to Time 24 Hours (AUC0-24) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Maximum Plasma Concentration (Cmax) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Time to Reach Cmax (Tmax) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length=21 or 28 days) |
| Secondary | Median Time Taken for the First Response Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Median Time Taken for the Best Overall Response Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Progression Free Survival Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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 |
|---|---|
| 33311588 | 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/NCT01987362
GET https://conductscience.org/api/trials/v1/NCT01987362/registered