SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03272464

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma. The drugs involved in this study are: - Itacitinib (INCB039110) - Dabrafenib - Trametinib

NCT03272464 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: Trametinib

Description: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.
Type: Drug
Group Labels: 1

Trametinib + Dabrafenib + INCB039110

Name: Dabrafenib

Description: Dabrafenib may work by stopping your cancer cells from duplicating.
Type: Drug
Group Labels: 1

Trametinib + Dabrafenib + INCB039110

Name: INCB039110

Description: Itacitinib may work by stopping your tumor cells from living and growing.
Type: Drug
Group Labels: 1

Trametinib + Dabrafenib + INCB039110


Primary Outcomes

Description: Doses at which fewer than one third of patients have severe toxicity

Measure: Maximum Tolerated Dose

Time: 2 years

Secondary Outcomes

Description: Proportion of patients with tumor shrinkage that meets standard criteria for response

Measure: Objective Response Rate

Time: 2 years

Description: Time until worsening of cancer

Measure: Progression Free Survival

Time: 6 Months

Description: Time until death from cancer

Measure: Overall Survival

Time: 1 year

Description: Proportion of patients with complete tumor shrinkage

Measure: Complete response rate

Time: 2 years

Description: Proportion of patients with less than complete tumor shrinkage

Measure: Partial Response Rate

Time: 2 years

Description: Proportion of patients with no change in tumor size

Measure: Stable Disease

Time: 2 years

Description: Proportion of patients with worsening of cancer at or before first response assessment

Measure: Progressive Disease

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---

- For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy. --- V600E ---

Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---



HPO Nodes


HPO: