XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
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|ClinicalTrials.gov Identifier: NCT02721459|
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Skin Cancer||Drug: XL888 Drug: Vemurafenib Drug: Cobimetinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Escalating Doses of XL888 With Vemurafenib Plus Cobimetinib for Patients With Unresectable BRAF Mutated Stage III/IV Melanoma|
|Actual Study Start Date :||August 11, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Dose Escalation
Escalating Doses of XL888 with Vemurafenib plus Cobimetinib.
Level 1: XL888 30 mg by mouth (PO) twice weekly (BIW). Level 2: XL888 45 mg PO BIW.
Level 3: XL888 60 mg PO BIW. Level 4: XL888 90 mg PO BIW.
Other Name: HSP90 inhibitorDrug: Vemurafenib
Vemurafenib 720 mg by mouth twice a day (BID)
Other Name: Zelboraf ®Drug: Cobimetinib
Cobimetinib 40 mg by mouth once daily (QD). Administered 3 weeks on, 1 week off.
Other Name: GDC-0973/XL518
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 months ]The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus cobimetinib in patients with BRAF V600 mutated melanoma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721459
|Contact: Leticia Tettehfirstname.lastname@example.org|
|Contact: Zeynep Eroglu, M.D.||email@example.com|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Principal Investigator: Zeynep Eroglu, M.D.|
|Sub-Investigator: Andrew Brohl, M.D.|
|Sub-Investigator: Nikhil Khushalani, M.D.|
|Sub-Investigator: Joseph Markowitz, M.D., Ph.D.|
|Sub-Investigator: Amod Sarnaik, M.D.|
|Sub-Investigator: Vernon Sondak, M.D.|
|Sub-Investigator: Jonathan Zager, M.D.|
|Sub-Investigator: Trevor Rose, M.D.|
|Principal Investigator:||Zeynep Eroglu, M.D.||H. Lee Moffitt Cancer Center and Research Institute|