Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
NCT02257424 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-01-20
Summary
The primary purpose of this study is to determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.
Conditions
- Advanced BRAF Mutant Melanoma
Interventions
- DRUG
-
Trametinib 2 mg daily
- DRUG
-
hydroxychloroquine (HCQ)
hydroxychloroquine (HCQ) is 600 mg orally every 12 hours
- DRUG
-
dabrafenib 150 mg orally twice a day
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Ravi Amaravadi, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2021-10-31
- Completion
- 2021-10-31
Countries
- United States
Study Locations
More Related Trials
-
Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma
NCT03088176 ·Status: UNKNOWN ·Phase: PHASE1
-
MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma
NCT03979651 ·Status: COMPLETED ·Phase: NA
-
An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor
NCT01619774 ·Status: COMPLETED ·Phase: PHASE2
-
Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases
NCT02974803 ·Status: TERMINATED ·Phase: PHASE2
-
Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread
NCT02196181 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma
NCT02447939 ·Status: WITHDRAWN ·Phase: PHASE1
-
Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
NCT01989585 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation
NCT05275374 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Hydroxychloroquine and Temozolomide in Treating Patients With Metastatic or Unresectable Solid Tumors
NCT00714181 ·Status: COMPLETED ·Phase: PHASE1
-
LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations
NCT01726738 ·Status: COMPLETED ·Phase: PHASE2
-
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma
NCT03455764 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery
NCT01701037 ·Status: TERMINATED ·Phase: PHASE2
-
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
NCT01597908 ·Status: COMPLETED ·Phase: PHASE3
-
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT02097225 ·Status: TERMINATED ·Phase: PHASE1
-
Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations
NCT02296112 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
NCT02034110 ·Status: COMPLETED ·Phase: PHASE2
-
Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer
NCT01902173 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation
NCT01682213 ·Status: COMPLETED ·Phase: PHASE2
-
Trametinib With GSK2141795 in BRAF Wild-type Melanoma
NCT01941927 ·Status: COMPLETED ·Phase: PHASE2
-
Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
NCT00909831 ·Status: COMPLETED ·Phase: PHASE1
-
Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)
NCT04439292 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
NCT05876806 ·Status: RECRUITING ·Phase: PHASE2
-
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
NCT04903119 ·Status: RECRUITING ·Phase: PHASE1
-
Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib
NCT02538627 ·Status: TERMINATED ·Phase: PHASE1
-
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
NCT01072175 ·Status: COMPLETED ·Phase: PHASE2