Trial · NCT01985763
Genistein in Treatment of Metastatic Colorectal Cancer
NCT01985763, Phase 1, Phase 2, Completed, Sofya Pintova; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genistein in Treatment of Metastatic Colorectal Cancer. Trials, record NCT01985763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01985763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genistein in Treatment of Metastatic Colorectal Cancer
- NCT number
- NCT01985763
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Sofya Pintova
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- Interventions
- Genistein
- First posted
- 2013-11-15
- Last updated
- 2019-05-10
- Results first posted
- 2019-05-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events | up to 6 months | Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle. |
| Primary | Percent Change in Tumor Size | end of Cycle 6 | Percent change in tumor size after cycle 6. Each cycle is 21 days. |
| Secondary | Response Rate RECIST Criteria | end of Cycle 6 | Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Number of Participants With an Overall Response Rate (ORR) | up to 50 months | Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period |
| Secondary | Best Overall Response Rate RECIST Criteria | up to 50 months | Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions. |
| Secondary | Number of Participants With Best Overall Response Rate (ORR) | up to 50 months | The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. |
| Secondary | Progression Free Survival (PFS) | up to 50 months | Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. |
| Secondary | Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months | 6 month and 12 month | Patients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. |
| Secondary | Overall Survival (OS) | up to 50 months | Overall Survival - Number of months still living since baseline |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events | up to 6 months | events | NUMBER | |
| PRIMARY | Percent Change in Tumor Size | end of Cycle 6 | Percent change | MEDIAN | |
| SECONDARY | Response Rate RECIST Criteria | end of Cycle 6 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Overall Response Rate (ORR) | up to 50 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Best Overall Response Rate RECIST Criteria | up to 50 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Best Overall Response Rate (ORR) | up to 50 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) | up to 50 months | months | MEDIAN | |
| SECONDARY | Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months | 6 month and 12 month | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | up to 50 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events | Genistein | Grade 1 | 250 | events | |
| Number of Adverse Events | Genistein | Grade 2 | 119 | events | |
| Number of Adverse Events | Genistein | Grade 3 | 24 | events | |
| Number of Adverse Events | Genistein | Grade 4 | 0 | events | |
| Percent Change in Tumor Size | Genistein | -43.0 | 95% Confidence Interval -49.8 to -1.3 | Percent change | |
| Response Rate RECIST Criteria | Genistein | PR | 8 | Participants | |
| Response Rate RECIST Criteria | Genistein | SD | 1 | Participants | |
| Response Rate RECIST Criteria | Genistein | PD | 2 | Participants | |
| Response Rate RECIST Criteria | Genistein | Not evaluable | 2 | Participants | |
| Number of Participants With an Overall Response Rate (ORR) | Genistein | 6 | Participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genistein | 13 | |
| Overall Study | COMPLETED | Genistein | 13 | |
| Overall Study | NOT COMPLETED | Genistein | 0 |
Source ClinicalTrials.gov
Adverse events44
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 | Fatigue | General disorders | Genistein | 2 | 13 | 6 |
| other | Fatigue | General disorders | Genistein and Chemotherapy | 11 | 13 | 55 |
| other | Hot Flashes | General disorders | Genistein | 2 | 13 | 8 |
| other | Hot Flashes | General disorders | Genistein and Chemotherapy | 1 | 13 | 1 |
| other | Mucositis | General disorders | Genistein | 0 | 13 | 0 |
| other | Mucositis | General disorders | Genistein and Chemotherapy | 5 | 13 | 11 |
| other | Hypertension | Cardiac disorders | Genistein | 1 | 13 | 2 |
| other | Hypertension | Cardiac disorders | Genistein and Chemotherapy | 12 | 13 | 88 |
| other | Rash | Skin and subcutaneous tissue disorders | Genistein | 2 | 13 | 4 |
| other | Rash | Skin and subcutaneous tissue disorders | Genistein and Chemotherapy | 0 | 13 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genistein | 0 | 13 |
| Total, all-cause mortality | Genistein and Chemotherapy | 0 | 13 |
| Total, other adverse events | Genistein | 13 | 13 |
| Total, other adverse events | Genistein and Chemotherapy | 13 | 13 |
| Total, serious adverse events | Genistein | 0 | 13 |
| Total, serious adverse events | Genistein and Chemotherapy | 0 | 13 |
Source ClinicalTrials.gov
Papers24
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Genistein vs Genistein and Chemotherapy: deaths from any cause | Trial comparisons |
| Genistein vs Genistein and Chemotherapy: serious adverse events | Trial comparisons |
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/NCT01985763
GET https://conductscience.org/api/trials/v1/NCT01985763/events?page=2