Determinants of the recommended phase 2 dose of molecular targeted agents
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DOI: 10.1002/cncr.30579
Abstract: The recommended phase 2 dose (RP2D) of anticancer agents is determined traditionally by dose‐limiting toxicities. Nontoxicity or biological endpoints such as pharmacokinetics, pharmacodynamics, and efficacy can also be used to identify RP2D, which may be… read more here.
Keywords: targeted agents; phase dose; determinants recommended; recommended phase ... See more keywords
PHARMACOKINETIC ANALYSIS AND CLINICAL RESULTS OF THE PHASE 1 DOSE ESCALATION AND EXPANSION CXD101 TRIAL IN RELAPSED, REFRACTORY LYMPHOMA
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DOI: 10.1002/hon.2439_186
Abstract: and anemia (12%). The overall response rate (ORR) was 71% (12/17 pts) and median progression‐free survival (PFS) was not estimable across all cohorts; ORR in each subtype was 80% (4/5 pts) in DLBCL with 1… read more here.
Keywords: cll; clinical results; analysis clinical; results phase ... See more keywords
Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study
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DOI: 10.1038/s41416-018-0235-2
Abstract: BackgroundThis phase 1 dose-escalation trial studied MM-302, a novel HER2-targeted PEGylated antibody–liposomal doxorubicin conjugate, in HER2-positive locally advanced/metastatic breast cancer.MethodsPatients were enrolled in four cohorts: MM-302 monotherapy (8, 16, 30, 40, and 50 mg/m2 every 4… read more here.
Keywords: phase; dose escalation; her2 targeted; cancer ... See more keywords
Safety, antitumor activity, and pharmacokinetics (PK) of pamiparib (BGB-290), a PARP1/2 inhibitor, in patients (pts) with advanced solid tumours: Updated phase I dose-escalation/expansion results
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DOI: 10.1093/annonc/mdz244.014
Abstract: Abstract Background Pamiparib is an investigational PARP1/2 inhibitor that has demonstrated brain penetration and PARP–DNA complex trapping in preclinical studies. In the phase 1 dose-escalation/expansion study of pts with advanced solid tumors, pamiparib was generally… read more here.
Keywords: phase dose; escalation expansion; oncology; dose escalation ... See more keywords
A Phase 1b Dose Escalation Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft-tissue Sarcoma
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DOI: 10.1158/1078-0432.ccr-20-0591
Abstract: Purpose: NC-6300 is a novel nanoparticle formulation of epirubicin that has a pH-sensitive linker conjugated to epirubicin. It exhibits selective tumor accumulation owing to enhanced permeability and retention effect. We conducted a phase 1b trial… read more here.
Keywords: soft tissue; phase dose; solid tumors; trial ... See more keywords
Abstract CT129: HyPeR: A phase 1, dose escalation and expansion trial of guadecitabine (SGI-110), a second-generation hypomethylating agent in combination with pembrolizumab (MK3475) in patients with refractory solid tumors
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DOI: 10.1158/1538-7445.am2020-ct129
Abstract: Background: Methylation is reported to support cancer immune tolerance. We conducted a phase 1 dose-escalation trial [NCT02998567] of combination guadecitabine (G; DNA hypomethylating agent) and pembrolizumab (P) in patients (pts) with advanced cancers. We hypothesized… read more here.
Keywords: dose escalation; treatment; cancer; phase dose ... See more keywords
Abstract CT138: Molecular markers in a phase I dose expansion study of PF-06801591 in locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma
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DOI: 10.1158/1538-7445.am2020-ct138
Abstract: Introduction: PF-06801591 is a humanized IgG4 monoclonal antibody that binds to the programmed cell death (PD-1) receptor and blocks its interaction with PD-1/2 ligands (PD-L1/2). In a phase 1 dose expansion study (NCT02573259), 106 patients… read more here.
Keywords: dose expansion; cancer; phase dose; cell ... See more keywords
Abstract CT202: Xevinapant plus avelumab in patients (pts) with advanced or metastatic non-small cell lung cancer (NSCLC): Phase 1b dose-expansion results and exploratory biomarker analyses
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DOI: 10.1158/1538-7445.am2023-ct202
Abstract: BACKGROUND: Combining anti-PD-1/L1 antibodies and agents that restore cancer cell susceptibility to apoptosis may enhance antitumor activity. We report results from a phase 1b dose-expansion cohort of xevinapant, a first-in-class, oral, small-molecule IAP (inhibitor of… read more here.
Keywords: cell; phase dose; pts advanced; cancer ... See more keywords
Abstract OT3-06-07: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
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DOI: 10.1158/1538-7445.sabcs17-ot3-06-07
Abstract: Background: Advanced or metastatic ER+BC (estrogen receptor positive breast cancer) is an incurable illness that will prove fatal for most afflicted women. Current standards of care include endocrine, targeted, and chemotherapy. Preclinical data suggest that… read more here.
Keywords: combination; phase; breast cancer; cancer ... See more keywords
Phase I/II dose-finding design for molecularly targeted agent: Plateau determination using adaptive randomization
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DOI: 10.1177/0962280216631763
Abstract: Conventionally, phase I dose-finding trials aim to determine the maximum tolerated dose of a new drug under the assumption that both toxicity and efficacy monotonically increase with the dose. This paradigm, however, is not suitable… read more here.
Keywords: dose finding; efficacy; molecularly targeted; phase dose ... See more keywords
Backfilling cohorts in phase I dose-escalation studies.
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DOI: 10.1177/17407745231160092
Abstract: Background: The use of ‘backfilling’, assigning additional patients to doses deemed safe, in phase I dose-escalation studies has been used in practice to collect additional information on the safety profile, pharmacokinetics and activity of a… read more here.
Keywords: escalation studies; dose escalation; phase; phase dose ... See more keywords