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Protocol No. UW19140

Principal Investigator Uboha, Nataliya

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors

Objective The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an investigational drug), given together with palbociclib (an approved drug), and if it has an effect on your type of cancer. "Investigational" means that telaglenastat has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies. Approved means that palbociclib has been tested and approved for sale by the FDA and can be prescribed by your doctor. The combination of using telaglenastat together with palbociclib is also investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies

Treatment
Part 1, Dose Escalation: Escalating (or de-escalating) doses of telaglenastat starting at 600 mg twice daily (BID) on Days 1 to 28 in combination with escalating doses of palbociclib administered once daily (QD) for 21 days followed by 7 days off in each 28-day cycle
Part 2, Cohort Expansion: Combination treatment with telaglenastat and palbociclib at the dose determined in Part 1

Description A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors.

Key Eligibility
Part 1(dose escalation): histologically or cytologically documented incurable, locally advanced or metastatic solid tumors refractory or intolerant to standard therapies with proven clinical benefit, or with no therapy of clinically meaningful benefit, required to have evaluable disease
Part 2(Cohort Expansion): Cohort 1: Incurable locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy, including oxaliplatin-, irinotecan- and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab OR Cohort 2: Cohort 2: Incurable locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy including platinum-based and anti-PD-1/PDL-1 therapy (unless contraindicated)
All patients:
  • 18 years of age or older
  • ECOG PS 0-1
  • Evaluable disease(part 1) OR measurable disease(part 2), requires tumor biopsy if archival tissue not available
  • Adequate renal, hematologic and kidney function as defined by the protocol
  • Can not be pregnant or breastfeeding and must agree to adequate birth control as defined by the protocol
    EXCLUSION(all patients)
  • prior treatment with telaglenastat or palbociclib
  • Receipt of any anticancer therapy within windows defined by the protocol
  • Symptomatic ascites or pleural effusion
  • Unable to receive oral medications
  • Unstable cardiac function as defined by the protocol
  • Current or anticipated use of medication with potential drug-drug interactions (DDI)with palbociclib
  • Inability to discontinue proton pump inhibitor use before randomization
  • Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1
  • Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
  • Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption
  • Serious psychiatric or medical conditions that could interfere with treatment or protocol-related procedures
  • Active and/or untreated central nervous system metastasis. Patients with treated brain metastases must have :Documented radiographic stability of at least 4 weeks duration demonstrated on baseline CNS imaging prior to study treatment AND b. Be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment
  • Any other current or previous malignancy within the past three years

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics