Combination With Gemcitabine in Advanced Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 11/16/2018 |
| Start Date: | January 1, 2011 |
| End Date: | August 1, 2013 |
A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus
gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine
(1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:
response duration, disease control rate, time to progression, progression-free survival,
overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and
weekly throughout the study; Safety follow-up visit 30 days after the last dose of study
treatment; Survival follow up monthly for up to 8 month after LPFV.
gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine
(1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:
response duration, disease control rate, time to progression, progression-free survival,
overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and
weekly throughout the study; Safety follow-up visit 30 days after the last dose of study
treatment; Survival follow up monthly for up to 8 month after LPFV.
Inclusion Criteria:
- Male or female patients ≥18 years of age
- Histological or cytologically confirmed locally advanced, inoperable or metastatic
pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
- Patients must have at least one uni-dimensional measurable lesion by CT or MRI
according to RECIST, Version 1.1
- Resolution of all acute toxic effects of any prior local treatment to Common
Terminology Criteria for Adverse Events (CTCAE) Grade
- Eastern Cooperative Oncology Group performance status (ECOG PS)
- Patient has cardiac function, within normal range, as measured by an echocardiogram
Exclusion Criteria:
- Known history of, or symptomatic metastatic brain or meningeal tumors
- History of cardiac disease
- Active clinically serious infections
- Clinically significant (ie. symptomatic) peripheral vascular disease
- Pregnant or lactating women; women of childbearing potential not employing adequate
contraception
- Use of strong inhibitors or inducers of CYP3A4
- Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic
cancer, or other malignancy
- Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers
to radiation therapy in adjuvant intention if given within 6 months from start of
study treatment
- Thrombotic or embolic events such within 6 months prior to start of study treatment
We found this trial at
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