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A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
Bu çalışma, Telaglenastat (CB-839) ilacının Palbociclib ile birlikte kullanımını, ilerlemiş veya metastatik solid tümörleri (özellikle KRAS mutasyonlu kalın bağırsak, akciğer ve pankreas kanserleri) olan hastalarda değerlendirmiştir. Standart tedavilere yanıt vermeyen veya bunları tolere edemeyen hastalar katılabilmiştir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit. * Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy will be required if archival tissue is not available) * Part 2, Cohort 1: Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy (examples include: oxaliplatin-, irinotecan-and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab) * Part 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) * Part 2, Cohort 3: Advance KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) harboring a mutation or loss in CDKN2A (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy Cohort 4 may be opened only if Cohort 3 achieves predefined criteria for efficacy -Part 2 Cohort 4: Advanced KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC). · Histological or cytological diagnosis of advanced or metastatic KRAS-mutant with CDKN2A wild type (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy. For both Part 1 and 2: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Ability to provide written consent in accordance with federal, local and institutional guidelines * PER RECIST v1.1 evaluable disease (for part 1) or measurable disease (for Part 2) * Recovery to baseline or to Grade 1 CTCAE v5.0 of toxicities that were related to prior therapies Exclusion Criteria: * Prior treatment with CB-839 or palbociclib * Unable to receive oral medication * Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1 * Unable to discontinue proton pump inhibitor use before study treatment * 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 * Active and/or untreated central nervous system metastasis. Patients with treated brain metastasis must have (1) documented radiographic stability of at least 4 weeks in duration demonstrating on baseline central nervous system imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment. * Major surgery within 28 days prior to first dose of study drug * Receipt of any anticancer therapy within the following windows: 1. small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose 2. any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose 3. radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1 4. patients with clinically relevant ongoing complications from prior radiation therapy are not eligible