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Completed

NCT Number: NCT01251640

Combination With Gemcitabine in Advanced 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.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bruxelles - Brussel, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 </= 1
  • Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
  • 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

Treatment and study plan

BAY86-9766+Gemcitabine

Drug

Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)

Primary outcomes

  1. Number of Subjects With Dose Limiting Toxicities (DLT): Phase I

    Time frame: From randomization up to the first 8 weeks of therapy

  2. Tumor Response (Adjudicated Blinded Read Assessment): Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

Secondary outcomes

  1. Tumor Response: Investigator Assessment: Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  2. Disease Control (DC): Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  3. Disease Control (DC): Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  4. Duration of Response (DOR): Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  5. Duration of Response: Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  6. Time to Progression (TTP): Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  7. Time to Progression (TTP): Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  8. Progression-Free Survival (PFS): Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  9. Progression-Free Survival (PFS): Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  10. Overall Survival (OS): Phase I

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

  11. Overall Survival (OS): Phase II

    Time frame: From start of treatment until 134 weeks assessed every 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

Acronym: BAGPAC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2010
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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