Trial · NCT01807546
Oral Rigosertib for Squamous Cell Carcinoma
NCT01807546, Phase 2, Completed, Traws Pharma, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Rigosertib for Squamous Cell Carcinoma. Trials, record NCT01807546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01807546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Rigosertib for Squamous Cell Carcinoma
- NCT number
- NCT01807546
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Traws Pharma, Inc.
- Conditions
Head and Neck Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, Lung Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Penile Squamous Cell Carcinoma
- Interventions
- rigosertib
- First posted
- 2013-03-08
- Last updated
- 2017-06-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate | Baseline to 9 weeks after start of rigosertib treatment and every 9 weeks thereafter, up to 2 years. | Outcome is defined as the number of patients with Complete Response (CR) or Partial Response (PR) per revised Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Overall survival (OS) | Date of signing ICF to date of death, or date last known to be alive up to 2 years after discontinuation of rigosertib treatment. | At the time of analysis, the outcome measure will be number of days between the date the patient is enrolled in the study and the date the patient dies or date the patient is last known to be alive, up to 2 years following discontinuation of rigosertib treatment. |
| Secondary | Progression free survival (PFS), | 9 weeks, 18 weeks, and 27 weeks and every 9 weeks thereafter, up to 2 years after patient enrolled in the study. | At the time of analysis, the outcome measure will be number of days between the date the patient is enrolled in the study and the date that progressive disease (PD) is documented per revised Response Evaluation Criteria In Solid Tumors (RECIST 1.1). |
| Secondary | Concentration of rigosertib in plasma | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 2 Day 14 at 0, 0.5, 1, 1.5, 2, and 6 hours after the first dose of the day. | The concentration (expressed as microgram rigosertib per mL plasma and/or nanogram rigosertib per mL plasma) of rigosertib in plasma will be determined by a validated high performance liquid chromatography (HPLC) method. |
| Secondary | Levels of Biomarkers | Baseline ( study before drug administration) and Cycle 1, Day 14. | Genetic and protein profiling will be conducted in blood (collected at Baseline before study drug administration) and in core biopsy or fine needle aspirate tumor samples (collected at Baseline before study drug administration and at Cycle 1 Day 14). |
| Secondary | Number of Adverse Events | From signing of Informed Consent Form until 30 days after last dose of study drug. | All Adverse Events reported by the patient or observed by the Investigator or study site personnel will be recorded. An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that appears or worsens in a patient during the period of observation in a clinical study. |
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 |
|---|---|
| 23873848 | BACKGROUND |
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/NCT01807546
GET https://conductscience.org/api/trials/v1/NCT01807546/registered