Trial · NCT03366103
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Change in BAX and MCl-1 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 | Pharmacodynamic Parameters | Up to 1.5 years | Exploratory correlative studies with pharmacodynamic (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
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GET https://conductscience.org/api/trials/v1/NCT03366103/registered