Trial · NCT01222780
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
NCT01222780, Phase 1, Completed, Acrotech Biopharma Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer. Trials, record NCT01222780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
- NCT number
- NCT01222780
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Acrotech Biopharma Inc.
- Conditions
- Sarcoma, Neuroblastoma, Wilms Tumor, Leukemia, Lymphoma, Brain Tumors
- Interventions
- Marqibo
- First posted
- 2010-10-18
- Last updated
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Define the toxicity spectrum of Marqibo in children with cancer | up to 48 weeks | Toxicity was graded according to the version 4.0 of the NCI Common Toxicity Criteria (CTCAE v4.0). |
| Primary | Determine of Marqibo® administered as a 60 minute intravenous infusion weekly (every 28 days constitute 1 cycle), in children and adolescents with refractory solid tumors and hematologic malignancies. | up to 48 weeks | The MTD was defined as the dose level immediately below the dose level at which ≥2 subjects in a cohort of 2 to 6 subjects experienced a DLT. |
| Primary | Determine dose limiting toxicities (DLT) of Marqibo® administered as a 60 minute intravenous infusion weekly (every 28 days constitute 1 cycle), in children and adolescents with refractory solid tumors and hematologic malignancies. | up to 48 weeks | DLT was graded according to the version 4.0 of the NCI Common Toxicity Criteria (CTCAE v4.0). Adverse events (AEs) that were considered disease-related (not suspected of relationship to Marqibo) were not considered dose-limiting toxicities. Only those AEs deemed suspected of a relationship to Marqibo were used in the definition of DLT. |
| Secondary | Evaluate the plasma pharmacokinetics of Marqibo in children with cancer. | 28 days | PK samples were collected at cycle 1 before start of first infusion, 5 minutes post-infusion and at 1, 3, 6, 10, 24, 48, 72, 96, 120 and 144 hours (pre-dose #2 trough level). Area under the concentration time curve (AUC) to last measured time point after dose one was calculated via linear trapezoidal method and extrapolated to infinity (AUC0-∞) by adding the last plasma concentration after dose one divided by the rate constant, derived from the slope of the natural log-transformed concentrations and times on the terminal elimination phase of the concentration-time curve. |
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/NCT01222780
GET https://conductscience.org/api/trials/v1/NCT01222780/registered