Phase II, Open-label, Study in Subjects with BRAF V600E - Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib (BRF117019)

Phase 2

Recruiting

• Conditions: various rare malignant tumors; 10027655

• Registration Number: NL-OMON50511
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

• Males and females, 18 years and above.
• BRAF mutation positive tumor.
• ECOG Performance Status 0-2.
• Advanced disease, no standard treatment options.
• ATC, BTC, GIST, NSGCT/NGGCT, ASI: at least 1 measurable lesion.
• Females of childbearing potential: adequate method of contraception.,
Histology-specific criteria, see protocol:
• Anaplastic Thyroid Cancer: page 61.
• Biliary Tract Cancer: page 61.
• Gastrointestinal Stromal Tumors: page 61.
• WHO Grade 1 and 2 Glioma: page 61.
• WHO Grade 3 and 4 Glioma: page 62.
• Germ Cell Tumors: page 62.
• Adenocarcinoma of the Small Intestine: page 63.
• Hairy Cell Leukemia: page 63.
• Multiple Myeloma: page 64.

Exclusion Criteria

• Prior treatment with BRAF and/or MEK inhibitor.
• Anti-cancer therapy within 21 days (or within 42 days if prior nitrosourea or
mitomycin C containing therapy) prior to enrollment and/or daily or weekly
chemotherapy without the potential for delayed toxicity within 14 days prior to
enrollment.
• Chemotherapy or biologic therapy within 14 days prior to enrolment without
evidence of delayed toxicity.
• Investigational drug(s) within 30 days or 5 half-lives, whichever is longer,
prior to enrollment.
• Prior radiotherapy treatment and/or major surgery less than 14 days prior to
enrolment. Exceptions: see protocol page 51.
• History of interstitial lung disease or pneumonitis.
• Neurological involvement, see protocol page 52-53 for details.
• A history of retinal vein occlusion.
• A history or evidence of cardiovascular risk, see protocol page 53-54 for
details.
• Pregnancy or breastfeeding, Histology-specific criteria, see protocol:
• Anaplastic Thyroid Cancer: page 67.
• Biliary Tract Cancer: page 67.
• WHO Grade 1 and 2 Glioma: page 67.
• WHO Grade 3 and 4 Glioma: page 67.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Survival, adverse effects.</p><br>