Clinical trialPhase 1Withdrawn
Dovitinib Lactate, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Solid Tumors or Pancreatic Cancer
A Phase Ib Study of Dovitinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer
- Outcome
- Stopped earlyLack of funding (Business decision)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- March 2015
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Maximum tolerated dose of dovitinib lactate, defined as the highest dose level at which < 33% of patients experience study treatment-related dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0; Incidence of adverse events graded by NCI CTCAE version 4.0
- Sponsor
- Other
- Results posted
- No
- Last update
- 9 January 2015
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation are anti-cancer drugs for treating many cancer types.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and recommended phase II dose of dovitinib (dovitinib lactate) when administered concurrently with gemcitabine (gemcitabine hydrochloride) and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced solid malignancies. II. To characterize the safety profile of dovitinib, gemcitabine and nab-paclitaxel combination in patients with advanced solid malignancies. SECONDARY OBJECTIVES: I. To characterize the pharmacokinetic profile of dovitinib, nab-paclitaxel, gemcitabine and their metabolites when administered concurrently in patients with advanced solid malignancies. II. To determine the preliminary efficacy of the study combination in patients with advanced solid tumors and pancreas adenocarcinoma. III. To explore serum and tumor biomarkers predictive of efficacy to the study combination. OUTLINE: This is a dose-escalation study of dovitinib lactate. Patients receive dovitinib lactate orally (PO) once daily (QD) 5 days per week, paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.