Trial · NCT01239342
Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer
NCT01239342, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer. Trials, record NCT01239342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01239342
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer
- NCT number
- NCT01239342
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Kidney Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
- Interventions
- Akt Inhibitor MK2206, Everolimus, Laboratory Biomarker Analysis
- First posted
- 2010-11-11
- Last updated
- 2019-10-10
- Results first posted
- 2017-06-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) in Months | Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years | PFS defined as Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first. Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. |
| Secondary | Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Up to 5 years | Clinical benefit defined as participants' with CR+PR+SD assessed using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): \>20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase \>5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters. |
| Secondary | Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 5 years | Adverse Events (AEs) list of reported events with associated intervention agent in a uniform presentation of events. The method of Thall, Simon and Estey (1995, 1996) was used to collect study participants' safety data summarized by treatment arm, category, severity and relevance. Comprehensive listing of AEs collected on study can be found in Adverse Event section separated by severity, Serious and Other AEs and represented by treatment arm, organ system-category within defined severity. |
| Secondary | Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR) | Up to 5 years | Response for CR + PR defined by RECIST version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): \>20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase \>5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters. |
| Secondary | Median Overall Survival (OS) in Months | Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years | Overall survival reported in months as time interval between the date of treatment and the date of death or last follow-up. |
| Secondary | Time to Failure (TTF) | Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years | TTF defined as Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival (PFS) in Months | Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years | One participant in each group left study before restaging therefore are excluded from response outcome analysis. | Months | MEDIAN |
| SECONDARY | Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Up to 5 years | One participant in each group left study before restaging therefore are excluded from outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 5 years | Toxicities | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR) | Up to 5 years | One participant in each group left study before restaging therefore are excluded from response outcome analysis. | percentage of participants | NUMBER |
| SECONDARY | Median Overall Survival (OS) in Months | Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years | Months | MEDIAN | |
| SECONDARY | Time to Failure (TTF) | Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years | No participants analyzed. Data not collected. |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression Free Survival (PFS) in Months | MK2206 | 3.68 | 95% Confidence Interval 1.77 to 5.75 | Months | |
| Median Progression Free Survival (PFS) in Months | Everolimus | 5.98 | 95% Confidence Interval 5.03 to NA | Months | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | MK2206 | Complete Response | 1 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Everolimus | Complete Response | 0 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | MK2206 | Partial Response | 3 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Everolimus | Partial Response | 0 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | MK2206 | Stable Disease | 11 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Everolimus | Stable Disease | 11 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | MK2206 | Progressive Disease | 13 | Participants | |
| Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | Everolimus | Progressive Disease | 2 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK2206 | 29 | |
| Overall Study | STARTED | Everolimus | 14 | |
| Overall Study | COMPLETED | MK2206 | 26 | |
| Overall Study | COMPLETED | Everolimus | 8 | |
| Overall Study | NOT COMPLETED | MK2206 | 3 | |
| Overall Study | NOT COMPLETED | Everolimus | 6 |
Source ClinicalTrials.gov
Adverse events296
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 | Gastrointestinal disorders | MK2206 | 0 | 29 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus | 1 | 14 | |
| other | Abdominal infection | Infections and infestations | MK2206 | 0 | 29 | |
| other | Abdominal infection | Infections and infestations | Everolimus | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | MK2206 | 8 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | Everolimus | 3 | 14 | |
| other | Activated partial thromboplastin time prolonged | Investigations | MK2206 | 18 | 29 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Everolimus | 3 | 14 | |
| other | Alanine aminotransferase increased | Investigations | MK2206 | 4 | 29 | |
| other | Alanine aminotransferase increased | Investigations | Everolimus | 1 | 14 |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK2206 | 0 | 29 |
| Total, all-cause mortality | Everolimus | 0 | 14 |
| Total, other adverse events | MK2206 | 29 | 29 |
| Total, other adverse events | Everolimus | 13 | 14 |
| Total, serious adverse events | MK2206 | 7 | 29 |
| Total, serious adverse events | Everolimus | 2 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MK2206 vs Everolimus: deaths from any cause | Trial comparisons |
| MK2206 vs Everolimus: 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/NCT01239342
GET https://conductscience.org/api/trials/v1/NCT01239342/results?page=2