Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03366103
Other study ID # NCI-2017-00037
Secondary ID NCI-2017-00037ET
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date March 20, 2018
Est. completion date September 21, 2022

Study information

Verified date September 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II trial studies the best dose and side effects of navitoclax and how well it works when given together with vistusertib in treating patients with small cell lung cancer and solid tumors that have come back (relapsed). Drugs used in chemotherapy, such as navitoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vistusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving navitoclax and vistusertib may work better than navitoclax alone in treating patients with small cell lung cancer and solid tumors.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms

Read more »

Intervention

Biological:
Navitoclax
Given PO
Drug:
Vistusertib
Given PO

See more »

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in p4EBP1 Expression Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. Baseline up to 1.5 years
Other Change in Ratio p4EBP1/4EBP1 Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. Baseline up to 1.5 years
Other Change in Ratio pS6/S6 Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. Baseline up to 1.5 years
Other Change in BAX and MCl-1 Expression Descriptive statistics and box plots with jittered data points will be used to visualize all raw data. Will be assessed with paired t-tests. Baseline up to 1.5 years
Other Pharmacodynamic Parameters Exploratory correlative studies with pharmacodynamic (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics. Up to 1.5 years
Primary Number of Participants With Dose Limiting Toxicities (Phase I) 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. Up to 30 days after last treatment, an average of 3 months
Primary Overall Response Rate (ORR) (Phase II) 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. Up to 1.5 years
Secondary Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Concentrations of each study agent present in the blood at the specified time point are reported for each study agent. Through Day 15
Secondary Number of Participants Experiencing Adverse Events by Grade (Phase II) 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. Up to 1.5 years
Secondary Progression Free Survival (PFS) (Phase II) 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. Up to 1.5 years
Secondary Overall Survival (OS) at Year 1 (Phase II) Standard life table methods will be used to analyze OS. We will report the one-year and median OS with 95% confidence intervals. At Year 1
Secondary Disease Control Rate (Phase II) Based on RECIST 1.1. The proportion of patients achieving disease control will be reported with exact 95% binomial confidence intervals. Up to 1.5 years
See also
  Status Clinical Trial Phase
Completed NCT02317874 - Testing the Addition of the Anti-Cancer Drug Talazoparib to the Combination of Carboplatin and Paclitaxel for the Treatment of Advanced Cancer Phase 1
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Not yet recruiting NCT05095948 - Improving Processes of Cancer Care Delivery at a Comprehensive Cancer Center
Recruiting NCT05691491 - Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness Phase 1/Phase 2
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT05554380 - Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial Phase 2
Recruiting NCT04957615 - Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression Phase 2
Active, not recruiting NCT04294628 - Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03065387 - Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation Phase 1
Withdrawn NCT04820894 - Perception of Cure Among Patients With Metastatic Cancer
Completed NCT03229278 - Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma Phase 1
Recruiting NCT02408861 - Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Recruiting NCT04673448 - Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Recruiting NCT05638295 - Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) Phase 2
Recruiting NCT05455606 - Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment N/A
Recruiting NCT05101356 - A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma Phase 1/Phase 2
Recruiting NCT04960787 - Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses N/A
Recruiting NCT05803382 - Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers Phase 1
Active, not recruiting NCT02143401 - Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors Phase 1