Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, with an Expansion Cohort in RAS Mutated Cancers

Objective

To determine the RP2D of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors

Protocol #

MCC-17-13821

Trial Phase:

Phase I/II

Principal Investigator:

Poklepovic, Andrew

Cancer Type
  • Anus
  • Bones and Joints
  • Breast
  • Cervix
  • Colon
  • Corpus Uteri
  • Esophagus
  • Eye and Orbit
  • Kidney
  • Larynx
  • Lip
  • Oral Cavity and Pharynx
  • Liver
  • Lung
  • Melanoma
  • Skin
  • Other Digestive Organ
  • Other Endocrine System
  • Other Female Genital
  • Other Male Genital
  • Other Respiratory and Intrathoracic Organs
  • Other Skin
  • Other Urinary
  • Ovary
  • Pancreas
  • Prostate
  • Rectum
  • Small Intestine
  • Soft Tissue
  • Stomach
  • Thyroid
Study Site
  • Stony Point
  • Virginia Commonwealth University

- Phase 1 - Dose Escalation Phase: Advanced solid tumor that has progressed during or after treatment with approved
therapies or for which there is no standard effective therapy available
- Phase 2 - Dose Expansion Phase: One of the following advanced solid tumors that is RAS-mutated and has progressed
during or after treatment with approved therapies or for which there is no standard effective therapy available:
- Colon Cancer
- Pancreatic Cancer
- Other Solid Tumor
- Measurable or evaluable disease by RECIST v1.1
- Age >= 18 years

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Faith McFadden, MSN, RN
    Phone: +1 804-628-0616
    Email Study Contact

Click "I'm Interested" to get started. If you have questions, call our study contact.

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