Trial · NCT01633541
Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
NCT01633541, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer. Trials, record NCT01633541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01633541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
- NCT number
- NCT01633541
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Laryngeal Cancer
- Interventions
- AT-101, Docetaxel, Cisplatin, Carboplatin
- First posted
- 2012-07-04
- Last updated
- 2023-07-20
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | Up to 3 months after end of treatment | The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy |
| Primary | Progression-free Survival | Up to 3 years after randomization | Time from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method. |
| Primary | Overall Response Rate (ORR) | Up to approximately 60 days | ORR (Complete Response \[CR\] plus Partial Response \[PR\]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer. |
| Primary | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Up to 3 years after end of treatment | Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3. |
| Secondary | Head and Neck Related Quality of Life (QOL) | Up to 28 months post treatment | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. |
| Secondary | Voice Related QOL | Up to 28 months post treatment | The University of Michigan Voice Related Quality of Life Measure (V-RQOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-50 (10 items scale 1-5) with high scores indicating a worse outcome. |
| Secondary | Functional Assessment QOL | Up to 28 months post treatment | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. EATING Domain is reported here as a functional assessment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | Up to 3 months after end of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Progression-free Survival | Up to 3 years after randomization | percentage of participants | NUMBER | |
| PRIMARY | Overall Response Rate (ORR) | Up to approximately 60 days | This outcome measure only applies to those subjects treated with induction chemotherapy with platinum and docetaxel plus AT-101 and therefore only one arm is being reported | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Up to 3 years after end of treatment | percentage of Patients | NUMBER | |
| SECONDARY | Head and Neck Related Quality of Life (QOL) | Up to 28 months post treatment | Number of participants analyzed varies below based on completion compliance | units on a scale | MEDIAN |
| SECONDARY | Voice Related QOL | Up to 28 months post treatment | number of participants analyzed varies due to patient compliance and patients coming off trial per protocol | score on a scale | MEDIAN |
| SECONDARY | Functional Assessment QOL | Up to 28 months post treatment | Number of participants analyzed varies below based on completion compliance | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group127
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | Platinum/Docetaxal + AT-101 | 27 | Participants | ||
| Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | Active Comparator Arm | 12 | Participants | ||
| Progression-free Survival | Platinum/Docetaxal + AT-101 | 55 | 95% Confidence Interval 35 to 71 | percentage of participants | |
| Progression-free Survival | Active Comparator Arm | 65 | 95% Confidence Interval 36 to 84 | percentage of participants | |
| Overall Response Rate (ORR) | Platinum/Docetaxal + AT-101 | 27 | Participants | ||
| Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Platinum/Docetaxal + AT-101 | 61 | percentage of Patients | ||
| Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Active Comparator Arm | 44 | percentage of Patients | ||
| Head and Neck Related Quality of Life (QOL) | Platinum/Docetaxal + AT-101 | Emotion- Prior to treatment | 66.7 | Inter-Quartile Range 41.7 to 79.2 | units on a scale |
| Head and Neck Related Quality of Life (QOL) | Active Comparator Arm | Emotion- Prior to treatment | 62.5 | Inter-Quartile Range 58.3 to 75 | units on a scale |
| Head and Neck Related Quality of Life (QOL) | Platinum/Docetaxal + AT-101 | Emotion- 6 months | 66.7 | Inter-Quartile Range 41.7 to 95.8 | units on a scale |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Platinum/Docetaxal + AT-101 | 36 | |
| Overall Study | STARTED | Active Comparator Arm | 18 | |
| Overall Study | COMPLETED | Platinum/Docetaxal + AT-101 | 35 | |
| Overall Study | COMPLETED | Active Comparator Arm | 18 | |
| Overall Study | NOT COMPLETED | Platinum/Docetaxal + AT-101 | 1 | |
| Overall Study | NOT COMPLETED | Active Comparator Arm | 0 |
Source ClinicalTrials.gov
Adverse events314
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 distention | Gastrointestinal disorders | Platinum/Docetaxal + AT-101 | 0 | 36 | 0 |
| other | Abdominal distention | Gastrointestinal disorders | Active Comparator Arm | 1 | 18 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Platinum/Docetaxal + AT-101 | 1 | 36 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Active Comparator Arm | 0 | 18 | 0 |
| other | Acne | Infections and infestations | Platinum/Docetaxal + AT-101 | 0 | 36 | 0 |
| other | Acne | Infections and infestations | Active Comparator Arm | 1 | 18 | 1 |
| other | Alanine aminotransferase increased | Investigations | Platinum/Docetaxal + AT-101 | 4 | 36 | 4 |
| other | Alanine aminotransferase increased | Investigations | Active Comparator Arm | 1 | 18 | 1 |
| other | Alkaline phosphatase increased | Investigations | Platinum/Docetaxal + AT-101 | 1 | 36 | 2 |
| other | Alkaline phosphatase increased | Investigations | Active Comparator Arm | 3 | 18 | 5 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Platinum/Docetaxal + AT-101 | 1 | 36 |
| Total, all-cause mortality | Active Comparator Arm | 1 | 18 |
| Total, other adverse events | Platinum/Docetaxal + AT-101 | 36 | 36 |
| Total, other adverse events | Active Comparator Arm | 18 | 18 |
| Total, serious adverse events | Platinum/Docetaxal + AT-101 | 14 | 36 |
| Total, serious adverse events | Active Comparator Arm | 5 | 18 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Platinum/Docetaxal + AT-101 vs Active Comparator Arm: deaths from any cause | Trial comparisons |
| Platinum/Docetaxal + AT-101 vs Active Comparator Arm: Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | Trial comparisons |
| Platinum/Docetaxal + AT-101 vs Active Comparator Arm: 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/NCT01633541
GET https://conductscience.org/api/trials/v1/NCT01633541/results?page=2