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Phase Ib Study of Dovitinib in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Plus Carboplatin in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Bladder Cancer

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Trial Information

Phase Ib Study of Dovitinib in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Plus Carboplatin in Patients With Advanced Solid Tumors


This is a phase Ib study of dovitinib given in combination with gemcitabine plus cisplatin
or carboplatin in patients with advanced solid tumors. This study will utilize standard 3+3
dose escalation rules to define the recommended phase II dose. Dose escalation will proceed
independently in the two cohorts (cisplatin cohort: gemcitabine + cisplatin + dovitinib;
carboplatin cohort: gemcitabine + carboplatin + dovitinib). Patients will receive treatment
for up to 6 cycles, in the absence of toxicity, until disease progression

Primary Objective:

To determine the recommended phase II dose of dovitinib given in combination with
gemcitabine plus cisplatin or carboplatin.

Secondary Objectives:

- To determine the response rate to treatment as per Response Evaluation Criteria in
Solid Tumors (RECIST)

- To determine the toxicity of treatment at per the Common Terminology for Adverse Events
(CTCAE v4)

- To determine the pharmacokinetics of dovitinib in combination with gemcitabine plus
cisplatin or carboplatin.


Inclusion Criteria:



- Written informed consent and HIPAA authorization for release of personal health
information.

- Age ≥ 18 years at the time of consent.

- Karnofsky Performance Status of ≥ 70%.

- Advanced/metastatic solid tumor for which treatment with gemcitabine plus carboplatin
or gemcitabine plus cisplatin would otherwise be warranted.

- Prior treatment with chemotherapy is permitted. Patients must not have received more
than three prior chemotherapeutic regimens.

- Adequate organ function as determined by the following laboratory values:

- Hemoglobin (Hgb) ≥ 9 g/dL

- Platelets ≥ 100 x 109/L

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

- Creatinine of ≤ 1.5 OR Calculated creatinine clearance of ≥ 60 cc/min for the
cisplatin cohort.

Calculated creatinine clearance of ≥ 30 cc/min for the carboplatin cohort.

- Bilirubin ≤ 1.5 x ULN

- Aspartate aminotransferase (AST, SGOT) ≤ 1.5 ULN

- Alanine Aminotransferase (ALT, SGPT) < 1.5 ULN

- INR ≤ 1.5 and a PTT within normal limits

- LVEF assessed by 2-D echocardiogram (ECHO) > 50% or lower limit of normal or multiple
gated acquisition scan (MUGA) > 45% or lower limit of normal

Exclusion Criteria:

- Prior treatment with more than three prior chemotherapy regimens.

- Has had major surgery within 30 days of starting the study treatment

- Have active CNS metastases.

- No treatment with any investigational agent within 30 days prior to being registered
for protocol therapy.

- Prior cancer treatment must be completed at least 30 days prior to being registered
for protocol therapy and the subject must have recovered from the acute toxic effects
of the regimen.

- Prior radiation therapy must be completed at least 30 days prior to being registered
for protocol therapy.

- Pregnant or breastfeeding.

- Clinically significant infections as judged by the treating investigator.

- Impaired cardiac function or clinically significant cardiac diseases

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

- Patients who are currently receiving anticoagulation treatment with therapeutic doses
of warfarin

- Women of child-bearing potential, who are biologically able to conceive, not
employing two forms of highly effective contraception.

- Fertile males not willing to use contraception

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose of combination regimen

Outcome Description:

The primary objectives of this study are to determine the recommended phase II dose of dovitinib given in combination with gemcitabine plus carboplatin or cisplatin.

Outcome Time Frame:

Within the first 21 days of treatment

Safety Issue:

Yes

Principal Investigator

Matthew D. Galsky, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

11-0946

NCT ID:

NCT01496534

Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Solid Tumors
  • Bladder Cancer
  • advanced solid tumors
  • bladder cancer
  • gemcitabine
  • cisplatin
  • carboplatin
  • solid tumors
  • Urinary Bladder Neoplasms
  • Neoplasms

Name

Location

Mount Sinai Medical CenterNew York, New York  10029