Trial · NCT01097512
AS703569 and Gemcitabine Combination in Advanced Malignancies
NCT01097512, Phase 1, Completed, Merck KGaA, Darmstadt, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AS703569 and Gemcitabine Combination in Advanced Malignancies. Trials, record NCT01097512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01097512
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AS703569 and Gemcitabine Combination in Advanced Malignancies
- NCT number
- NCT01097512
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 66 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Pancreatic Cancer
- Interventions
- AS703569/gemcitabine, AS703569/gemcitabine
- First posted
- 2010-04-01
- Last updated
- 2014-01-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | 21 days | To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine. |
| Secondary | Treatment-emergent adverse events (TEAE) | Minimum 21 days or 1 cycle | Proportion/number of subjects with TEAE's during the first and subsequent treatment cycles in each cohort for each of the 2 regimens. |
| Secondary | Progression-Free Survival (PFS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part) | Variable | PFS time is defined as time (in months) from first drug intake to date of progression as reported and documented by the investigator (i.e. radiological progression per Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) or death from any cause. |
| Secondary | Time to Tumor Progression (TTP) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part) | Variable | TTP time is defined as the time (in months)from first drug intake to the date of progression, as reported and documented by the Investigator (i.e. radiological progression per RECIST). |
| Secondary | Overall Survival (OS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part) | Variable | OS time is defined as the time (in months) from first drug intake to any cause of death. |
| Secondary | Progressive disease (PD) | Every other cycle | Proportion of patients with progressive disease as assessed at the end of every other cycle according to disease-specific guidelines |
| Secondary | Best overall response (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part) | Every other cycle | For subjects with locally advanced /metastatic pancreatic cancer: Best overall response: presence of at least one confirmed Complete Response (CR) or confirmed Partial Response (PR) (using RECIST v1.0) during treatment in the 2 regimens as assessed at the end of every other cycle. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23539344 | RESULT |
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 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/NCT01097512
GET https://conductscience.org/api/trials/v1/NCT01097512/registered