Trial · NCT03366103
Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors
NCT03366103, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2023-05-03
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors. Trials, record NCT03366103. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03366103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors
- NCT number
- NCT03366103
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Malignant Solid Neoplasm, Recurrent Lung Small Cell Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Stage III Lung Small Cell Carcinoma, by American Joint Committee on Cancer (AJCC) v7, Stage IIIA Lung Small Cell Carcinoma AJCC v7, Stage IIIB Lung Small Cell Carcinoma AJCC v7, Stage IV Lung Small Cell Carcinoma AJCC v7, Unresectable Solid Neoplasm
- Interventions
- Navitoclax, Vistusertib
- First posted
- 2017-12-08
- Last updated
- 2023-10-17
- Results first posted
- 2023-05-03
- Limitations and caveats
- Only 1 participant was enrolled to Phase 2 before the study was closed to accrual for low accrual.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (Phase I) | Up to 30 days after last treatment, an average of 3 months | Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. The number of participants with dose limiting toxicities at each dose level will be reported with exact binomial 95% confidence intervals. All patients who receive at least 1 dose of both study drugs, regardless of their eligibility for the study, will be evaluable for toxicity. |
| Primary | Overall Response Rate (ORR) (Phase II) | Up to 1.5 years | Defined as Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. partial response or complete response, of the combination in patients with recurrent small cell lung cancer. The ORR will be reported with its corresponding 95% confidence interval. |
| Secondary | Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Through Day 15 | Concentrations of each study agent present in the blood at the specified time point are reported for each study agent. |
| Secondary | Number of Participants Experiencing Adverse Events by Grade (Phase II) | Up to 1.5 years | Graded by NCI CTCAE v 4.0. The number of participants with toxicities by grade in the phase 2 study will be reported with exact binomial 95% confidence intervals. |
| Secondary | Progression Free Survival (PFS) (Phase II) | Up to 1.5 years | Based on RECIST 1.1. Standard life table methods will be used to analyze PFS. We will report the one-year and median PFS with 95% confidence intervals. |
| Secondary | Overall Survival (OS) at Year 1 (Phase II) | At Year 1 | Standard life table methods will be used to analyze OS. We will report the one-year and median OS with 95% confidence intervals. |
| Secondary | Disease Control Rate (Phase II) | Up to 1.5 years | Based on RECIST 1.1. The proportion of patients achieving disease control will be reported with exact 95% binomial confidence intervals. |
| Other | Change in p4EBP1 Expression | Baseline up to 1.5 years | Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. |
| Other | Change in Ratio p4EBP1/4EBP1 | Baseline up to 1.5 years | Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. |
| Other | Change in Ratio pS6/S6 | Baseline up to 1.5 years | Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Dose Limiting Toxicities (Phase I) | Up to 30 days after last treatment, an average of 3 months | Phase 1 participants were included in this analysis. Please see AE section for additional details. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (ORR) (Phase II) | Up to 1.5 years | Only one participant was enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Through Day 15 | Participants in both phases were included. Some data was not collected at each timepoint. | ng/ml | MEAN |
| SECONDARY | Number of Participants Experiencing Adverse Events by Grade (Phase II) | Up to 1.5 years | Only one participant was enrolled. | participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) (Phase II) | Up to 1.5 years | Only one participant was enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) at Year 1 (Phase II) | At Year 1 | Only one participant was enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (Phase II) | Up to 1.5 years | Only one participant was enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in p4EBP1 Expression | Baseline up to 1.5 years | Data was not collected. | ||
| OTHER_PRE_SPECIFIED | Change in Ratio p4EBP1/4EBP1 | Baseline up to 1.5 years | Data was not collected. | ||
| OTHER_PRE_SPECIFIED | Change in Ratio pS6/S6 | Baseline up to 1.5 years | Data was not collected. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group34
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 Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 1 | DLT | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 2 | DLT | 2 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 1 | No DLT | 6 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 2 | No DLT | 1 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Partial Response (PR) or Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Stable Disease (SD) | 0 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Progression (PD) | 1 | Participants | |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 1145 | Standard Deviation 289 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 1966 | Standard Deviation 999 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 2283 | ng/ml |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 - Dose Level 1 | 9 | |
| Overall Study | STARTED | Phase 1 - Dose Level 2 | 5 | |
| Overall Study | STARTED | Phase 2 | 1 | |
| Overall Study | COMPLETED | Phase 1 - Dose Level 1 | 6 | |
| Overall Study | COMPLETED | Phase 1 - Dose Level 2 | 3 | |
| Overall Study | COMPLETED | Phase 2 | 1 | |
| Overall Study | NOT COMPLETED | Phase 1 - Dose Level 1 | 3 | |
| Overall Study | NOT COMPLETED | Phase 1 - Dose Level 2 | 2 | |
| Overall Study | NOT COMPLETED | Phase 2 | 0 |
Source ClinicalTrials.gov
Adverse events234
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 | Diarrhea | Gastrointestinal disorders | Phase 1 - Dose Level 1 | 4 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | Phase 1 - Dose Level 2 | 2 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | Phase 2 | 1 | 1 | |
| other | Nausea | Gastrointestinal disorders | Phase 1 - Dose Level 1 | 3 | 9 | |
| other | Nausea | Gastrointestinal disorders | Phase 1 - Dose Level 2 | 3 | 5 | |
| other | Nausea | Gastrointestinal disorders | Phase 2 | 1 | 1 | |
| other | Vomiting | Gastrointestinal disorders | Phase 1 - Dose Level 1 | 5 | 9 | |
| other | Vomiting | Gastrointestinal disorders | Phase 1 - Dose Level 2 | 2 | 5 | |
| other | Vomiting | Gastrointestinal disorders | Phase 2 | 0 | 1 | |
| other | Constipation | Gastrointestinal disorders | Phase 1 - Dose Level 1 | 3 | 9 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 - Dose Level 1 | 6 | 9 |
| Total, all-cause mortality | Phase 1 - Dose Level 2 | 3 | 5 |
| Total, all-cause mortality | Phase 2 | 1 | 1 |
| Total, other adverse events | Phase 1 - Dose Level 1 | 9 | 9 |
| Total, other adverse events | Phase 1 - Dose Level 2 | 5 | 5 |
| Total, other adverse events | Phase 2 | 1 | 1 |
| Total, serious adverse events | Phase 1 - Dose Level 1 | 2 | 9 |
| Total, serious adverse events | Phase 1 - Dose Level 2 | 2 | 5 |
| Total, serious adverse events | Phase 2 | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39998620 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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/NCT03366103
GET https://conductscience.org/api/trials/v1/NCT03366103/results?page=2