Trial · NCT01730586
Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
NCT01730586, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas. Trials, record NCT01730586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01730586
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
- NCT number
- NCT01730586
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Colorectal Cancer, Cancer of Gastrointestinal Tract
- Interventions
- Abraxane
- First posted
- 2012-11-21
- Last updated
- 2020-01-18
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Assessed at 21 day cycle; Restaging done every 3 cycles | Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): \>20% increase (absolute increase \>5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) \[second tumor assessment not \<4 weeks from response observed\]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis. |
| Secondary | Progression-Free Survival (PFS) | Assessed at first cycle (21 days), up to 12 months | The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as "censored data". |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Assessed at 21 day cycle; Restaging done every 3 cycles | In the CIMP-CRC arm 15 participants were considered efficacy evaluable \[Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)\], and three were not evaluable in SBA arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | Assessed at first cycle (21 days), up to 12 months | For progression-free survival, the intent-to-treat analysis performed using all available participants. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | CIMP-high Colorectal Cancer | Complete Response | 0 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Small Bowel Adenocarcinoma (SBA) | Complete Response | 0 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | CIMP-high Colorectal Cancer | Partial Response | 0 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Small Bowel Adenocarcinoma (SBA) | Partial Response | 2 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | CIMP-high Colorectal Cancer | Stable Disease | 3 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Small Bowel Adenocarcinoma (SBA) | Stable Disease | 3 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | CIMP-high Colorectal Cancer | Progressive Disease | 12 | Participants | |
| Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) | Small Bowel Adenocarcinoma (SBA) | Progressive Disease | 5 | Participants | |
| Progression-Free Survival (PFS) | CIMP-high Colorectal Cancer | 2.1 | 95% Confidence Interval 1.7 to 2.5 | Months | |
| Progression-Free Survival (PFS) | Small Bowel Adenocarcinoma | 3.2 | 95% Confidence Interval 2.6 to 3.8 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abraxane | 34 | |
| Overall Study | COMPLETED | Abraxane | 21 | |
| Overall Study | NOT COMPLETED | Abraxane | 13 |
Source ClinicalTrials.gov
Adverse events115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Blood and lymphatic system disorders | Abraxane | 1 | 34 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Abraxane | 9 | 34 | 18 |
| other | Acute kidney injury | Renal and urinary disorders | Abraxane | 2 | 34 | 2 |
| other | Alanine aminotransferase increased | Investigations | Abraxane | 4 | 34 | 4 |
| other | Alkaline phosphatase increased | Investigations | Abraxane | 7 | 34 | 7 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Abraxane | 1 | 34 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Abraxane | 26 | 34 | 26 |
| other | Anemia | Blood and lymphatic system disorders | Abraxane | 12 | 34 | 15 |
| other | Anorexia | Metabolism and nutrition disorders | Abraxane | 9 | 34 | 10 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Abraxane | 12 | 34 | 20 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abraxane | 0 | 34 |
| Total, other adverse events | Abraxane | 34 | 34 |
| Total, serious adverse events | Abraxane | 20 | 34 |
Source ClinicalTrials.gov
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/NCT01730586
GET https://conductscience.org/api/trials/v1/NCT01730586/events?page=2