Trial · NCT01679405
BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
NCT01679405, Phase 1, Terminated, Johannes Gutenberg University Mainz; results first posted 2019-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer. Trials, record NCT01679405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01679405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
- NCT number
- NCT01679405
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Johannes Gutenberg University Mainz
- Conditions
- Metastatic Disease
- Interventions
- BIBW 2992
- First posted
- 2012-09-06
- Last updated
- 2019-09-06
- Results first posted
- 2019-01-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events | Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period. | In part A the maximum tolerated dose (MTD) of BIBW 2992 administered continuously to the standard therapy of Gemcitabine / Cisplatin (Gem/Cis) (administered together on day 1 and 8 of a three-week cycle) will be evaluated in a 2 step dose escalation. Safety and toxicity will be evaluated as described and considered primary for part B of the study. |
| Secondary | Time to Progress (TTP) | Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period. | Median time to progress (according to RECIST 1.1 criteria) including the 95% confidence intervals were determined using Kaplan-Meier estimates. Time from start of treatment to first documentation of objective tumour progression. Deaths were censored at the time of death. |
| Secondary | Overall Survival (OS) | Time from start of treatment to death due to any cause. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored. Estimated time period: up to 76 weeks | Median overall survival time including the 95% confidence interval were determined using Kaplan-Meier estimates. |
| Secondary | Objective Response Rate | Treatment period: up to eight cycles (maximum 8 months). | Response was assessed by means of RECIST 1.1 criteria for target lesions, non-target lesions and the appearance of new lesions. Objective response was defined as the CR, PR or SD at end of treatment |
| Secondary | Tumor Control Rate | Treatment period: up to eight cycles (maximum 8 months). | Tumor control rate is defined as the best tumour response (confirmed partial or complete response, stable disease) that is achieved until end of treatment according to Recist 1.1. |
Source ClinicalTrials.gov
Outcomes5
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 | Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progress (TTP) | Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period. | days | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Time from start of treatment to death due to any cause. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored. Estimated time period: up to 76 weeks | days | MEDIAN | |
| SECONDARY | Objective Response Rate | Treatment period: up to eight cycles (maximum 8 months). | For one patient, there was no CT assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tumor Control Rate | Treatment period: up to eight cycles (maximum 8 months). | For one patient there was no CT assessment. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Adverse Events | Dose Level 1 | 2 | Participants | ||
| Number of Adverse Events | Dose Level -1 | 1 | Participants | ||
| Time to Progress (TTP) | Dose Level 1 | 159 | 95% Confidence Interval 134 to 184 | days | |
| Time to Progress (TTP) | Dose Level -1 | NA | 95% Confidence Interval 49 to NA | days | |
| Overall Survival (OS) | Dose Level 1 | 163 | 95% Confidence Interval 79 to NA | days | |
| Overall Survival (OS) | Dose Level -1 | 260 | 95% Confidence Interval 75 to NA | days | |
| Objective Response Rate | Dose Level 1 | 0 | Participants | ||
| Objective Response Rate | Dose Level -1 | 0 | Participants | ||
| Tumor Control Rate | Dose Level 1 | 0 | Participants | ||
| Tumor Control Rate | Dose Level -1 | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 3 | |
| Overall Study | STARTED | Dose Level -1 | 6 | |
| Overall Study | COMPLETED | Dose Level 1 | 1 | |
| Overall Study | COMPLETED | Dose Level -1 | 1 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 2 | |
| Overall Study | NOT COMPLETED | Dose Level -1 | 5 |
Source ClinicalTrials.gov
Adverse events50
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 | Dose Level 1 | 3 | 3 | 11 |
| other | fatigue | General disorders | Dose Level -1 | 6 | 6 | 19 |
| other | nausea | Gastrointestinal disorders | Dose Level 1 | 3 | 3 | 5 |
| other | nausea | Gastrointestinal disorders | Dose Level -1 | 5 | 6 | 9 |
| other | diarrhoea | Gastrointestinal disorders | Dose Level 1 | 2 | 3 | 4 |
| other | diarrhoea | Gastrointestinal disorders | Dose Level -1 | 5 | 6 | 25 |
| other | rash | Skin and subcutaneous tissue disorders | Dose Level 1 | 3 | 3 | 7 |
| other | rash | Skin and subcutaneous tissue disorders | Dose Level -1 | 4 | 6 | 10 |
| other | stomatitis | Gastrointestinal disorders | Dose Level 1 | 3 | 3 | 6 |
| other | stomatitis | Gastrointestinal disorders | Dose Level -1 | 4 | 6 | 8 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 2 | 3 |
| Total, all-cause mortality | Dose Level -1 | 5 | 6 |
| Total, other adverse events | Dose Level 1 | 3 | 3 |
| Total, other adverse events | Dose Level -1 | 6 | 6 |
| Total, serious adverse events | Dose Level 1 | 2 | 3 |
| Total, serious adverse events | Dose Level -1 | 5 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30634942 | DERIVED |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 1 vs Dose Level -1: Number of Adverse Events | Trial comparisons |
| Dose Level 1 vs Dose Level -1: Objective Response Rate | Trial comparisons |
| Dose Level 1 vs Dose Level -1: Tumor Control Rate | Trial comparisons |
| Dose Level 1 vs Dose Level -1: deaths from any cause | Trial comparisons |
| Dose Level 1 vs Dose Level -1: 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/NCT01679405
GET https://conductscience.org/api/trials/v1/NCT01679405/events?page=2