Print Friendly Page

Protocol No. UW19007

Principal Investigator Emamekhoo, Hamid

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 CB-839 in Combination with the PARP inhibitor Talazoparib 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 talazoparib (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 talazoparib has been tested and approved for sale by the FDA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer and may not be approved for your cancer. The combination of using telaglenastat together with talazoparib 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 If you participate in Part 1of this study, you will be given telaglenastat (in a dose of either 600 mg or 800 mg twice daily) to be taken together with the approved dose of talazoparib, or as determined by safety and consensus of the study doctors and the sponsor
If you participate in Part 2 of the study, you will be given the dose of telaglenastat that was determined by Part 1 to be the best dosage to be taken together with the approved dose of talazoparib, or as determined by safety and consensus of the study doctors and the sponsor. The dose of either or both drugs may be decreased if you experience unacceptable side effects

Description Phase IB/2 Study of Glutaminase Inhibitor CB-839 +/- Parp Inhibitor Talazoparib in Advanced/Metastatic Solid Tumors

Key Eligibility Inclusion Criteria: Part 1, Dose Escalation: Have histologically or cytologically documented incurable/locally advanced or metastatic solid tumors refractory or intolerant to standard therapies of proven clinical benefit, or with no therapy of clinically meaningful benefit (in the opinion of the investigator and patient) and have evaluable disease
  • Disease-Specific Inclusion Criteria: Part 2, Cohort Expansion: . Cohort 1: Incurable/locally advanced or metastatic ccRCC having received 2 or more prior systemic regimens, including at least one vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy OR . Cohort 2: Incurable/locally advanced or metastatic TNBC defined as ER and PR negative (< 1% by immunohistochemistry) and HER2-negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization [FISH] negative) having received at least one prior line of cytotoxic chemotherapy for metastatic disease.
  • The following inclusion criteria apply: Has not previously received therapy for TNBC with a PARP inhibitor, has not previously received platinum therapy for TNBC in the metastatic setting and prior platinum in the adjuvant or neoadjuvant setting is allowed if the first disease recurrence occurred greater than 6 months after the last dose of platinum therapy OR Cohort 3: Incurable/locally advanced or metastatic CRC treated with prior systemic therapy, including oxaliplatin-, or irinotecan- and 5-FU-based chemotherapy (if appropriate) with or without bevacizumab
    All Patients (Part 1, Dose Escalation, and Part 2, Cohort Expansion): 18 years of age or older, ECOG PS 0-1, Evaluable disease (Part 1), OR Measurable disease (Part 2)
  • Adequate hematology, renal and kidney function as defined by the protocol
  • Can not be pregnant or breast feeding
  • Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION: All Patients (Part 1, Dose Escalation, and Part 2, Cohort Expansion)
  • Prior treatment with telaglenastat or a PARP inhibitor
  • Receipt of any anticancer therapy within windows as defined by the protocol
  • Patients with symptomatic ascites or pleural effusion
  • Unable to receive oral medications
  • Unstable/inadequate cardiac function as defined by the protocol
  • Requirement for continued proton pump inhibitor use after C1D1
  • Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to first dose of study drug
  • Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Active and/or untreated central nervous system metastasis
  • 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

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

    Status Open

    Participating Institutions UW Hospital and Clinics