Trial · NCT03281681
A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer
NCT03281681, Phase 1, Phase 2, Withdrawn, DelMar Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer. Trials, record NCT03281681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03281681
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer
- NCT number
- NCT03281681
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- DelMar Pharmaceuticals, Inc.
- Conditions
- Ovarian Cancer
- Interventions
- VAL-083, Dianhydrogalactitol
- First posted
- 2017-09-13
- Last updated
- 2019-10-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimate Overall Response Rate | Every 8 weeks from Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | Overall number of tumor complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI) |
| Secondary | Safety evaluation of VAL-083 for adverse events | From Screening up to 28 days following last study treatment with VAL-083 | Using NCI CTCAE version 4 criteria to assess frequency, severity and study drug relationship of clinically significant changes in vital signs, lab test results, EKGs or any other adverse events reported while patients are receiving treatment with VAL-083 |
| Secondary | Efficacy evaluation of VAL-083 against CA-125 biomarker | From Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | To measure the changes in concentration of CA-125 antigen levels in blood |
| Secondary | Progression-free Survival | Every 30 days from Screening until disease progression or patient death, whichever occurs first, for at least 6 months | Time from start of treatment until first occurrence of progression or patient death, whichever occurs first |
| Secondary | Comparative Progression-free Survival | Every 30 days from Screening until disease progression or patient death, whichever occurs first, for at least 6 months | Progression-free Survival for VAL-083 compared to Progression-free Survival for patient's last treatment regimen received |
| Secondary | Duration of Response | Every 8 weeks from Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | Time from start of treatment to achievement of either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI) |
| Secondary | Overall Survival | Every 30 days from Screening until patient death or for at least 6 months, whichever occurs first | Length of time from start of treatment until patient death |
| Secondary | Cmax | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083 |
| Secondary | Tmax | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Time of maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083 |
| Secondary | AUClast | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration of VAL-083 in plasma for the first 10 study subjects receiving VAL-083 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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.
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 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/NCT03281681
GET https://conductscience.org/api/trials/v1/NCT03281681/registered