Trial · NCT01666444
VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT01666444, Phase 2, Completed, Celgene; results first posted 2019-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. Trials, record NCT01666444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01666444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- NCT number
- NCT01666444
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 297 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Interventions
- pegylated liposomal doxorubicin (PLD), VTX-2337, Placebo
- First posted
- 2012-08-16
- Last updated
- 2019-09-26
- Results first posted
- 2019-09-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact. | Comparison of duration of survival between the 2 treatment groups |
| Secondary | Progression-free Survival (PFS) | Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment. | Comparison of PFS between the 2 treatment groups |
| Secondary | Frequency and Severity of Adverse Events (AEs) | Assessed during each cycle of therapy and within 30 days after the last cycle of therapy | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact. | All enrolled patients | days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment. | All enrolled patients. | days | MEDIAN |
| SECONDARY | Frequency and Severity of Adverse Events (AEs) | Assessed during each cycle of therapy and within 30 days after the last cycle of therapy | All patients who initiated study treatment. There were 147 patients who initiated treatment on each arm. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 574 | Inter-Quartile Range 242 to 1141 | days | |
| Overall Survival | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 552 | Inter-Quartile Range 240 to 869 | days | |
| Progression-free Survival (PFS) | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 159 | Inter-Quartile Range 87 to 351 | days | |
| Progression-free Survival (PFS) | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 147 | Inter-Quartile Range 85 to 267 | days | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD) + Placebo | Grade 1 | 8 | participants | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | Grade 1 | 3 | participants | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD) + Placebo | Grade 2 | 40 | participants | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | Grade 2 | 44 | participants | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD) + Placebo | Grade 3 | 83 | participants | |
| Frequency and Severity of Adverse Events (AEs) | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | Grade 3 | 90 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 149 | |
| Overall Study | STARTED | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 148 | |
| Overall Study | COMPLETED | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 147 | |
| Overall Study | COMPLETED | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 147 | |
| Overall Study | NOT COMPLETED | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 2 | |
| Overall Study | NOT COMPLETED | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 1 |
Source ClinicalTrials.gov
Adverse events772
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 | Anemia | Blood and lymphatic system disorders | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 103 | 147 | |
| other | Anemia | Blood and lymphatic system disorders | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 105 | 147 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 0 | 147 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 1 | 147 | |
| other | Atrial Fibrillation | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 1 | 147 | |
| other | Atrial Fibrillation | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 2 | 147 | |
| other | Ventricular Tachycardia | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 1 | 147 | |
| other | Ventricular Tachycardia | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 0 | 147 | |
| other | Sinus Bradycardia | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 1 | 147 | |
| other | Sinus Bradycardia | Cardiac disorders | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 2 | 147 |
1 to 10 of 772Source ClinicalTrials.gov
See all 772 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegylated Liposomal Doxorubicin (PLD) + Placebo | ||
| Total, all-cause mortality | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | ||
| Total, other adverse events | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 147 | 147 |
| Total, other adverse events | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 147 | 147 |
| Total, serious adverse events | Pegylated Liposomal Doxorubicin (PLD) + Placebo | 30 | 147 |
| Total, serious adverse events | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | 36 | 147 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pegylated Liposomal Doxorubicin (PLD) + Placebo vs Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX): serious adverse events |
Source 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/NCT01666444
GET https://conductscience.org/api/trials/v1/NCT01666444/events?page=2