Genetically-informed Therapies for Patients With Metastatic Cancer — GENIUS  

Metastatic Cancer Clinical Trial

Official title: Phase II GENIUS Trial of GENetically-Informed Therapies for Patients With previoUSly Treated Refractory Metastatic Cancer

Status Withdrawn

Clinical Trial Summary

Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region.

The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation.

Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.

The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing.

If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer.

If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.

Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).

Clinical Trial Description

Treatment with a personalized targeted therapy plan based on cancer genetics will improve time to disease progression (TTP) compared to standard therapies.

By comparing A) a patient's TTP on targeted therapy vs. B) their TTP on their most recent prior therapy, investigators will minimize the variability in TTP observed across cancer subtypes, and be able to enroll patients with any type of solid tumor in a statistically unbiased manner. Based on the literature, investigators expect at least 35% of patients treated with a genetically-informed targeted therapy to exhibit a longer progression-free interval than would be expected with standard therapies. This "TTP ratio" for each patient is calculated using the formula:

TTP ratio: (TTP on targeted therapy) / (TTP on most recent non-targeted therapy)

An individual patient's benefit from genetically-informed targeted therapy is defined as a TTP ratio ≥ 1.3 ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

• NCT number: NCT02000739
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2014
• Completion date: January 2018