Trial · NCT02192541
Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas
NCT02192541, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2018-01-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas. Trials, record NCT02192541. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02192541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas
- NCT number
- NCT02192541
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Neoplasms
- Interventions
- Ziv-Aflibercept, Ganetespib
- First posted
- 2014-07-17
- Last updated
- 2018-03-29
- Results first posted
- 2018-01-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 | Date treatment consent signed to date off study, approximately 12 months and 44 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Primary | Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Date treatment consent signed to date off study, approximately 12 months and 44 days | Adverse Events were graded according to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the Adverse Event. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE). AEs were considered possibly attributable to both study drugs, except where otherwise noted. Star (\*) symbol indicates that the AE is possibly related to Ziv-aflibercept and unlikely to be related to Ganetespib. |
| Primary | Maximum Tolerated Dose (MTD) of the Combination of Ganetespib and Ziv-aflibercept | Cycle one (28 days) | MTD is defined as the dose level at which no more than 1 of 6 patients experience a dose limiting toxicity (DLT) during the first cycle of the treatment, and the dose level below that at which at least 2 (of \<6) patients have a DLT as a result of the drug. Determination of DLT is based on the first cycle of treatment. |
| Secondary | Modulation of Hypoxia-Inducible Factor 1 (HIF-1) Alpha | Cycle 2, Day 7 | To determine whether the combination of ganetespib and ziv-aflibercept modulated intratumoral Hypoxia-inducible factor 1 (HIF-1)-alpha expression, tumor biopsies were to be analyzed for change in HIF-1-alpha expression by immunofluorescence assay (IFA). Paired pre-and post-combination treatment samples were to be compared for qualitative changes in levels of HIF-1- alpha expression. Cores were to be normalized against the percentage of tumor within the sample. |
| Secondary | Modulation of Epidermal Growth Factor Receptor (EGFR) Expression | Cycle 1 Day 16 | To evaluate for tumor distribution of EGFR, patients were to undergo 89Zr-immuno-positron emission tomography (PET) imaging with 89Zr-labeled EGFR-targeting panitumumab antibody evaluate modulation of EGFR client protein prior to and after treatment with the combination of ganetespib and ziv-aflibercept. Panitumumab is a fully human monoclonal antibody that targets EGFR and competes with endogenous ligands to block stimulation of EGFR. 89z-immuno-PET imaging with panitumumab as a targeting ligand allows for quantification of EGFR within tumors. |
| Secondary | Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) | Baseline and every 2 months up to 5 months | Radiologic response assessments by computed tomography (CT) scans were performed at baseline and every two cycles to evaluate tumor response based on the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions. |
| Secondary | Number of Cycles on Treatment | up to 5 months | The number of 28-day treatment cycles (ganetespib on days 1, 8, and 15; ziv-aflibercept on days 1 and 15) administered to each evaluable patient. Number represents treatment cycles that were started; not all cycles were completed. |
| Other | Number of Participants Who Had a Dose Limiting Toxicity (DLT) | Cycle one (28 days) | A DLT is defined as an adverse event that is related (possibly, probably, or definitely) to administration of study drugs during cycle one and is a Grade ≥ 3 non-hematological toxicity. Grade ≥3 non-hematological toxicity felt to be related to study medications are: Grade 3 diarrhea if it is refractory to treatment; Grade 3 nausea and vomiting if it is refractory to anti-emetic therapy and unable to be corrected; rise in creatinine to Grade 3, not corrected to Grade 1 or less within 48 hours with intravenous (IV) fluids; Any Grade 4 corrected QT interval (QTc) prolongation; Grade 4 neutropenia ≥5 days or febrile neutropenia,...). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 | Date treatment consent signed to date off study, approximately 12 months and 44 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Date treatment consent signed to date off study, approximately 12 months and 44 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of the Combination of Ganetespib and Ziv-aflibercept | Cycle one (28 days) | An MTD was not established because no MTD data were collected. The trial was terminated before the MTD was reached due to the decision of the drug supplier to suspend further clinical development of ganetespib. | ||
| SECONDARY | Modulation of Hypoxia-Inducible Factor 1 (HIF-1) Alpha | Cycle 2, Day 7 | Data were not collected from any participant. Biopsies were to be collected from an expansion cohort treated at the maximum tolerated dose, after the conclusion of the dose escalation phase. Trial was closed before the MTD was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained. | ||
| SECONDARY | Modulation of Epidermal Growth Factor Receptor (EGFR) Expression | Cycle 1 Day 16 | Data were not collected from any participant for this Outcome Measure. As the trial was closed before the maximum tolerated dose (MTD) was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained. | ||
| SECONDARY | Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) | Baseline and every 2 months up to 5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Cycles on Treatment | up to 5 months | The number of participants who were evaluable for response | cycles | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants Who Had a Dose Limiting Toxicity (DLT) | Cycle one (28 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 2 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | Participants | ||
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | Grade 2 Alanine Aminotransferase Increased | 0 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | Grade 2 Alanine Aminotransferase Increased | 1 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | Grade 2 Anorexia | 1 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | Grade 2 Anorexia | 0 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | Grade 2 Diarrhea | 1 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | Grade 2 Diarrhea | 0 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | Grade 2 EKG QT Corrected Interval Prolonged | 1 | Participants | |
| Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | Grade 2 EKG QT Corrected Interval Prolonged | 0 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 2 | |
| Overall Study | STARTED | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | |
| Overall Study | Treated | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 2 | |
| Overall Study | Treated | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | |
| Overall Study | Evaluable for Response | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 1 | |
| Overall Study | Evaluable for Response | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | |
| Overall Study | COMPLETED | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 2 | |
| Overall Study | COMPLETED | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | |
| Overall Study | NOT COMPLETED | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 0 |
Source ClinicalTrials.gov
Adverse events130
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 pain | Gastrointestinal disorders | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 1 | 2 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 1 | 2 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 1 | 3 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 0 | 2 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 1 | 3 | 2 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 1 | 2 |
| Total, all-cause mortality | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 2 | 3 |
| Total, other adverse events | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 2 | 2 |
| Total, other adverse events | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 3 | 3 |
| Total, serious adverse events | Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg | 1 | 2 |
| Total, serious adverse events | Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg | 2 | 3 |
Source ClinicalTrials.gov
Papers4
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg vs Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg: Number of Participants Who Had a Dose Limiting Toxicity (DLT) | Trial comparisons |
Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg vs Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg: Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 | Trial comparisons |
| Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg vs Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg: deaths from any cause | Trial comparisons |
| Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg vs Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg: 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT02192541/results?page=2