Trial · NCT02489903
RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
NCT02489903, Phase 2, Completed, EpicentRx, Inc.; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT). Trials, record NCT02489903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02489903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
- NCT number
- NCT02489903
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- EpicentRx, Inc.
- Conditions
- Small Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Neuroendocrine Tumors, Ovarian Epithelial Cancer
- Interventions
- RRx-001, Cisplatin, Etoposide, Carboplatin, Irinotecan, Vinorelbine, Doxil, Gemcitabine, Taxane, Paclitaxel, Nab-Paclitaxel, Pemetrexed
- First posted
- 2015-07-03
- Last updated
- 2025-03-17
- Results first posted
- 2025-03-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From start of treatment through death for up to 64 months from Start of Treatment. | From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death. |
| Secondary | Overall Response Rate (ORR) | Assessed up to 49 months | Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months. |
| Secondary | Disease Control Rate (DCR) | Assessed up to 49 months | The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months. |
| Secondary | Progression Free Survival (PFS) | Assessed up to 49 months | Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From start of treatment through death for up to 64 months from Start of Treatment. | Months | MEAN | |
| SECONDARY | Overall Response Rate (ORR) | Assessed up to 49 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate (DCR) | Assessed up to 49 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) | Assessed up to 49 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | RRx-001 + Platinum Doublet (A01-09) | 6.85 | 95% Confidence Interval 5.80 to 8.62 | Months | |
| Overall Survival | RRx-001 + Platinum + RRx-001 (A10) | 7.6 | 95% Confidence Interval 5.00 to NA | Months | |
| Overall Survival | Investigator's Choice (A10) | 7.5 | 95% Confidence Interval 3.00 to NA | Months | |
| Overall Response Rate (ORR) | RRx-001 + Platinum Doublet (A01-09) | 32 | Participants | ||
| Overall Response Rate (ORR) | RRx-001 + Platinum + RRx-001 (A10) | 3 | Participants | ||
| Overall Response Rate (ORR) | Investigator's Choice (A10) | 1 | Participants | ||
| Disease Control Rate (DCR) | RRx-001 + Platinum Doublet (A01-09) | 42 | Participants | ||
| Disease Control Rate (DCR) | RRx-001 + Platinum + RRx-001 (A10) | 8 | Participants | ||
| Disease Control Rate (DCR) | Investigator's Choice (A10) | 2 | Participants | ||
| Progression Free Survival (PFS) | RRx-001 + Platinum Doublet (A01-09) | 5.87 | 95% Confidence Interval 4.46 to 7.54 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening | STARTED | RRx-001 + Platinum Doublet (A01-09) | 118 | |
| Screening | STARTED | RRx-001 + Platinum + RRx-001 (A10) | 0 | |
| Screening | STARTED | Investigator's Choice (A10) | 0 | |
| Screening | STARTED | Screening (Pre-Randomization) (A10) | 21 | |
| Screening | COMPLETED | RRx-001 + Platinum Doublet (A01-09) | 94 | |
| Screening | COMPLETED | RRx-001 + Platinum + RRx-001 (A10) | 0 | |
| Screening | COMPLETED | Investigator's Choice (A10) | 0 | |
| Screening | COMPLETED | Screening (Pre-Randomization) (A10) | 13 | |
| Screening | NOT COMPLETED | RRx-001 + Platinum Doublet (A01-09) | 24 | |
| Screening | NOT COMPLETED | RRx-001 + Platinum + RRx-001 (A10) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events249
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 | Anaemia | Blood and lymphatic system disorders | RRx-001 + Platinum Doublet (A01-09) | 12 | 89 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | RRx-001 + Platinum + RRx-001 (A10) | 8 | 10 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Investigator's Choice (A10) | 2 | 2 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | RRx-001 + Platinum Doublet (A01-09) | 9 | 89 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | RRx-001 + Platinum + RRx-001 (A10) | 3 | 10 | 3 |
| other | Neutropenia | Blood and lymphatic system disorders | Investigator's Choice (A10) | 0 | 2 | 0 |
| other | Decreased appetite | Metabolism and nutrition disorders | RRx-001 + Platinum Doublet (A01-09) | 11 | 89 | 18 |
| other | Decreased appetite | Metabolism and nutrition disorders | RRx-001 + Platinum + RRx-001 (A10) | 0 | 10 | 0 |
| other | Decreased appetite | Metabolism and nutrition disorders | Investigator's Choice (A10) | 0 | 2 | 0 |
| other | Tumour pseudoprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | RRx-001 + Platinum Doublet (A01-09) | 11 | 89 | 11 |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RRx-001 + Platinum Doublet (A01-09) | 89 | 89 |
| Total, all-cause mortality | RRx-001 + Platinum + RRx-001 (A10) | 10 | 10 |
| Total, all-cause mortality | Investigator's Choice (A10) | 2 | 2 |
| Total, other adverse events | RRx-001 + Platinum Doublet (A01-09) | 89 | 89 |
| Total, other adverse events | RRx-001 + Platinum + RRx-001 (A10) | 10 | 10 |
| Total, other adverse events | Investigator's Choice (A10) | 2 | 2 |
| Total, serious adverse events | RRx-001 + Platinum Doublet (A01-09) | 55 | 89 |
| Total, serious adverse events | RRx-001 + Platinum + RRx-001 (A10) | 6 | 10 |
| Total, serious adverse events | Investigator's Choice (A10) | 2 | 2 |
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 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/NCT02489903
GET https://conductscience.org/api/trials/v1/NCT02489903/flow?page=2