SWOG clinical trial number
S1221

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."

Closed
Phase
I-II
Accrual
39%
Abbreviated Title
BRAF Mutant Metastatic Cancer
Status Notes
The study referenced above was temporarily closed to accrual on 10/31/2016.
Due to drug supply on this study, the study will be switched from temporarily closed to permanently closed with the same status date of 10/31/2016.
Activated
07/01/2013
Participants
Limited: Institutions Listed on the Title Page

Research committees

Melanoma
Gastrointestinal Cancer

Treatment

Dabrafenib GSK2141795 Trametinib Dimethyl Sulfoxide

Eligibility Criteria Expand/Collapse

Pt must have BRAF V600 mutant metastatic Ca irrespective of histology or prior therapy. BRAF mutant status must be documented by CLIA certified lab although use of an FDA-approved test is preferred. Pts progressing on prior BRAF inhibitor-based therapy & pts naive to BRAF inhibitor therapy are eligible. There will not be a break between progression on prior BRAF inhibitor therapy and start of protocol treatment. Prior systemic therapy (chemo, immuno, bio or combo), surgery and/or RT is allowed. Patients must have locally adv unresectable Stage IIIC or met Stage IV w/either progression to prior tx or newly diagnosed w/out available tx w/curative intent; have a complete physical exam and medical history w/in 28 days prior to reg; have measurable or non-measurable disease w/measurable lesions assessed w/in 28 days & tests to assess non-measurable disease performed w/in 42 days prior to reg; undergo CT or MRI of the brain w/in 42 days prior to reg; be willing to submit blood for PK; have available & be willing to submit baseline tissue taken at time of disease prog to prior BRAF inhibitor-based tx or have a site of disease that can be biopsied; have Zubrod PS of </= 1; have ANC >/= 1500, platelets >/= 100,000, hemoglobin >/= 9 g/dL, bili </= 1.5 x IULN, (or </= 2.5 x ULN for Gilbert's syndrome); AST & ALT </= 2.5 x IULN, creatinine </= 1.5 mg/dL or measured or calculated CrCl >/= 50 mL/min, LVEF >/= ILLN by ECHO or MUGA, and if melanoma LDH performed w/in 28 days prior to reg; if female, have negative pregnancy test w/in 14 days prior to reg; and be able to swallow capsules. HIV okay if pt not on antiviral agents and have adequate CD4 counts (>/= 500 mm3).

Patients must not have QTc >/= 480 msecs w/in 28 days prior to reg; have history of cardiac conditions per Sect 5.1r; be rec'g strong inhibitors or inducers of CYP3A or CYP2C8 or be planning to use herbal remedies or strong inhibitors or inducers of Pgp or Bcrp1 (see App 18.4); be pregnant or nursing; have uncontrolled intercurrent illness per 5.1y; have active Hep B or C virus infection; have history of allergic reaction per 5.1aa. Patients req'g therapeutic anticoagulation must have approval from physician per 5.1u.

Publication Information Expand/Collapse

2017

SWOG S1221: A phase 1 dose escalation study co-targeting MAPK-dependent and MAPK-independent BRAF inhibitor resistance in BRAF mutant advanced solid tumors with dabrafenib, trametinib, and GSK2141795 (ClinicalTrials.gov NCT01902173)

A Algazi;J Moon;B Chmielowski;RS Lo;K Kendra;C Lao;K Lewis;R Gonzalez;KB Kim;JE Godwin;BD Curti;M Othus;A Ribas J Clin Oncol 35, 2017 (suppl; abstr 2578); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster session

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SWOG Clinical Trial Number
S1815
SWOG Clinical Trial Number
S1613
SWOG Clinical Trial Number
CTSU/R1112

Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma

Research Committee(s)
Gastrointestinal Cancer
Symptom Control and Quality of Life
Activated
06/15/2016
Open
Phase
III