A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Cyteir Therapeutics, Inc.
- Study ID
- NCT03997968
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Breast Cancer
- CLL
- DLBCL
- Follicular Lymphoma
- Head and Neck Cancer
- Malignancy
- Mantle Cell Lymphoma
- Multiple Myeloma
- Non-hodgkin Lymphoma
- Ovarian Cancer
- Pancreatic Cancer
- Small Cell Lung Cancer
- Soft Tissue Sarcoma
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CYT-0851 — DRUGPart A and B: Daily oral doses of CYT-0851 for 28 day cycles
- CYT-0851 in combination with gemcitabine — DRUGPart D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine
- CYT-0851 in combination with capecitabine — DRUGPart E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine
- CYT-0851 in combination with rituximab and bendamustine — DRUGPart C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab and bendamustine
Study Details
This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.
Key Dates
- Start date
- Oct 9, 2019
- Status verified
- Dec 2024
- Primary completion
- Nov 30, 2024
- Completion
- Dec 20, 2024
Study Design
- Enrollment
- 169 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CYT-0851 dose escalationPart A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles
- Experimental: CYT-0851 dose expansionPart B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles
- Experimental: CYT-0851 and rituximab and bendamustinePart C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle
- Experimental: CYT-0851 and gemcitabinePart D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
- Experimental: CYT-0851 and capecitabinePart E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle
Primary Outcome Measure
Part A: Incidence of dose limiting toxicity [ Time Frame: 28 Days ]
Locations (16)
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University of California San Francisco· San Francisco, CAStanford Comprehensive Cancer Center· Stanford, CASarah Cannon Research Institute at HealthONE· Denver, COFlorida Cancer Specialists and Research Institute· Sarasota, FLDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA
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