Clincosm LogoSign in Get a demo

Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

Sponsor
George Albert Fisher (Other)
Overall Status
Completed
CT.gov ID
NCT00185588
Collaborator
Novartis (Industry)
33
Enrollment
1
Location
4
Arms
62
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 <Vatalanib> and Gemcitabine in Patients With Advanced Pancreatic Cancer
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Drug: Vatalanib
Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
Other Names:
  • PTK787
  • ZK 222584
  • PTK787/ZK 222584

    • Drug: Gemcitabine
    850 mg/m2
    Other Names:
  • Gemzar

    		•
    Experimental: Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250

    Gemcitabine 850 mg/m2 + vatalanib 1250 mg

    Drug: Vatalanib
    Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
    Other Names:
  • PTK787
  • ZK 222584
  • PTK787/ZK 222584

    • Drug: Gemcitabine
    850 mg/m2
    Other Names:
  • Gemzar

    		•
    Experimental: Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500

    Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

    Drug: Vatalanib
    Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
    Other Names:
  • PTK787
  • ZK 222584
  • PTK787/ZK 222584

    • Drug: Gemcitabine
    850 mg/m2
    Other Names:
  • Gemzar

    		•
    Experimental: Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500

    Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

    Drug: Vatalanib
    Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
    Other Names:
  • PTK787
  • ZK 222584
  • PTK787/ZK 222584

    • Drug: Gemcitabine
    850 mg/m2
    Other Names:
  • Gemzar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time-to-Treatment Failure (Intent-To-Treat Analysis) [12 months]

      For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

    Secondary Outcome Measures

    1. Time-to-Progression, Evaluable Patients [12 months]

      Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Unresectable (due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis)

    • If > 5 years between the primary surgery and the development of metastatic disease, then separate histological or cytological confirmation of metastatic disease

    • Primary or metastatic lesion within 4 weeks prior to entry of study

    • WHO performance status of 0 to 2

    • ≤ 18 years of age

    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10e9/L (>= 1500/mm3)

    • Platelets (PLT) ≥ 100 x 10^9/L (≥ 100,000/mm3)

    • Hemoglobin (Hgb) ≥ 9 g/dL

    • Serum creatinine ≤ 1.5 upper limit of normal (ULN)

    • Serum bilirubin ≤ 1.5 ULN

    • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase

    • (ALT/SGPT) ≤ 3.0 x ULN OR

    • ≤ 5 x ULN if liver metastases present

    • Proteinuria:

    • Negative for proteinuria based on dip stick reading OR

    • If dip stick reading is +1 result, then total urinary protein ≤ 500 mg and measured creatinine clearance (CrCl) ≥ 50 mL/min from a 24-hour urine collection

    • Life expectancy ≥ 12 weeks

    • Ability to give written informed consent

    Exclusion Criteria

    • For the "phase 1" portion of the study: prior gemcitabine will be therapy.

    • For the "phase 2" portion of the study: any prior chemotherapy {except for low-dose 5-fluorouracil (5-FU)as a radiosensitizer]

    • Radiotherapy (RT). The site of previous RT must have progressive disease if the only site of disease).

    • Prior full field radiotherapy ≤ 4 weeks prior to enrollment OR

    • Limited field radiotherapy ≤ 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities.

    • Prior biologic or immunotherapy ≤ 2 weeks prior to registration.

    • Prior therapy with anti-VEGF agents

    • History or presence of central nervous system (CNS) disease

    • Patients with a history of another primary malignancy ≤ 5 years (Exception: inactive basal or squamous cell carcinoma of the skin)

    • Major surgery ≤ 4 weeks prior to enrollment. (Exception: insertion of a vascular access device)

    • Minor surgery ≤ 2 weeks prior to enrollment. (Exception: insertion of a vascular access device)

    • Concurrent use of other investigational agents and patients who have received investigational drugs ≤ 4 weeks prior to enrollment.

    • Pregnant, or breast-feeding, not employing an effective method of birth control.

    • Pre-existing peripheral sensory neuropathy with functional impairment (≥ CTCAE grade 2 neuropathy)

    • Respiratory compromise due to pleural effusion or ascites (≥ CTCAE grade 2 dyspnea)

    • QTc > 450 ms (male) or > 470 ms (female)

    • Uncontrolled high blood pressure

    • History of labile hypertension

    • History of poor compliance with an antihypertensive regimen

    • Unstable angina pectoris

    • Symptomatic congestive heart failure

    • Myocardial infarction ≤ 6 months prior to registration / randomization

    • Serious uncontrolled cardiac arrhythmia

    • Uncontrolled diabetes

    • Active or uncontrolled infection

    • Interstitial pneumonia

    • Extensive and symptomatic interstitial fibrosis of the lung

    • Chronic renal disease

    • Acute or chronic liver disease

    • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib

    • Human immunodeficiency virus (HIV) infection (confirmed), if there is potential for interaction between vatalanib and any anti-HIV medication

    • HIV infection (confirmed) judged to increase subject risk due to the pharmacologic activity of vatalanib

    • Receiving warfarin sodium (Coumadin) or similar. Heparin is allowed.

    • Unwilling to or unable to comply with

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • George Albert Fisher
    • Novartis

    Investigators

    • Principal Investigator: George Albert Fisher M.D. Ph.D., Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George Albert Fisher, Associate Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00185588
    Other Study ID Numbers:
    • IRB-06999
    • 95533
    • CPTK787AUS08
    • PANC0002
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Sep 15, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine
    Vatalanib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Arm/Group Description Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 1250 mg Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2
    Period Title: Overall Study
    STARTED 6 4 6 17
    COMPLETED 3 2 0 13
    NOT COMPLETED 3 2 6 4

    Baseline Characteristics

    Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500 Total
    Arm/Group Description Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 1250 mg Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Total of all reporting groups
    Overall Participants 6 4 6 17 33
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    55
    69
    70
    55
    58
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    5
    83.3%
    2
    50%
    2
    33.3%
    13
    76.5%
    22
    66.7%
    >=65 years
    1
    16.7%
    2
    50%
    4
    66.7%
    4
    23.5%
    11
    33.3%
    Sex: Female, Male (Count of Participants)
    Female
    4
    66.7%
    2
    50%
    2
    33.3%
    7
    41.2%
    15
    45.5%
    Male
    2
    33.3%
    2
    50%
    4
    66.7%
    10
    58.8%
    18
    54.5%
    Region of Enrollment (participants) [Number]
    United States
    6
    100%
    4
    100%
    6
    100%
    17
    100%
    33
    100%

    Outcome Measures

    1. Primary Outcome
    Title Time-to-Treatment Failure (Intent-To-Treat Analysis)
    Description For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Arm/Group Description Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 1250 mg Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2
    Measure Participants 6 4 6 17
    Median (Full Range) [months]
    4.9
    2.7
    2.2
    3.7
    2. Secondary Outcome
    Title Time-to-Progression, Evaluable Patients
    Description Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Evaluable subset of subjects that terminated from the study due to disease progression (endpoint). No participants were analyzed in the "Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group" because no evaluable participants progressed within 12 months.
    Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Arm/Group Description Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 1250 mg Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2
    Measure Participants 3 2 0 13
    Median (Full Range) [months]
    4.4
    6.0
    3.2

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Arm/Group Description Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 1250 mg Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2 Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12 Gemcitabine: 850 mg/m2
    All Cause Mortality
    Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 4/4 (100%) 4/6 (66.7%) 10/17 (58.8%)
    Blood and lymphatic system disorders
    Anemia 1/6 (16.7%) 1 1/4 (25%) 2 0/6 (0%) 0 1/17 (5.9%) 2
    Febrile neutropenia 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 2
    Hemolysis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Abdominal pain 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 4/17 (23.5%) 4
    Abdominal pain-intractable pain 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Ascites 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Colitis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Constipation 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Diarrhea 2/6 (33.3%) 3 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Dyspepsia 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Enterocolitis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Gastritis 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Hemorrhoids 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Rectal hemorrhage 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Vomiting 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 0/17 (0%) 0
    General disorders
    Edema limbs 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Fatigue 2/6 (33.3%) 3 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Fever 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Hepatobiliary disorders
    Obstructed bile duct, stent placement 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Infections and infestations
    Neutropenia ANC 210 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Bladder 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Infections and infestations - not specified 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Urinary tract NOS 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Urosepsis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Lung Infection 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Urinary tract infection 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 0/17 (0%) 0
    Injury, poisoning and procedural complications
    Arterial injury 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Vascular access complication 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Alkaline phosphatase increased 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Blood bilirubin increased 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Neutrophil count decreased 2/6 (33.3%) 4 1/4 (25%) 1 1/6 (16.7%) 1 2/17 (11.8%) 3
    Platelet count decreased 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 2
    White blood cell decreased 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Metabolism and nutrition disorders
    Anorexia 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Dehydration 2/6 (33.3%) 2 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Hyperglycemia 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Hypokalemia 2/6 (33.3%) 3 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Hyponatremia 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Pain in extremity 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Nervous system disorders
    Peripheral sensory neuropathy 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Renal and urinary disorders
    Proteinuria 1/6 (16.7%) 2 0/4 (0%) 0 1/6 (16.7%) 2 0/17 (0%) 0
    Urinary tract obstruction 1/6 (16.7%) 2 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Vascular disorders
    Hypertension 1/6 (16.7%) 1 1/4 (25%) 2 0/6 (0%) 0 0/17 (0%) 0
    Thromboembolic event 2/6 (33.3%) 2 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Thromboembolic event-DVT 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Other (Not Including Serious) Adverse Events
    Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 3/4 (75%) 6/6 (100%) 14/17 (82.4%)
    Blood and lymphatic system disorders
    Anemia 4/6 (66.7%) 13 1/4 (25%) 4 3/6 (50%) 3 5/17 (29.4%) 12
    Febrile neutropenia 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 2/17 (11.8%) 2
    Cardiac disorders
    Cardiac disorders - not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Ear and labyrinth disorders
    Ear and labyrinth disorders-not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Eye disorders
    Blurred vision 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Abdominal distension 1/6 (16.7%) 1 1/4 (25%) 1 3/6 (50%) 3 1/17 (5.9%) 7
    Abdominal pain 6/6 (100%) 11 0/4 (0%) 0 1/6 (16.7%) 1 10/17 (58.8%) 16
    Constipation 4/6 (66.7%) 6 0/4 (0%) 0 1/6 (16.7%) 1 9/17 (52.9%) 10
    Diarrhea 3/6 (50%) 6 0/4 (0%) 0 1/6 (16.7%) 1 3/17 (17.6%) 6
    Dyspepsia 0/6 (0%) 0 0/4 (0%) 0 2/6 (33.3%) 2 3/17 (17.6%) 6
    Esophagitis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Flatulence 1/6 (16.7%) 2 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Gastric stenosis 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Gastric ulcer 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Gastritis 1/6 (16.7%) 2 1/4 (25%) 1 1/6 (16.7%) 1 1/17 (5.9%) 1
    Gastrointestinal disorders -not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 3/17 (17.6%) 3
    Hemorrhoids 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Mucositis oral 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Nausea 3/6 (50%) 4 1/4 (25%) 1 2/6 (33.3%) 2 12/17 (70.6%) 17
    Stomach pain 2/6 (33.3%) 2 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Toothache 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Vomiting 2/6 (33.3%) 2 0/4 (0%) 0 1/6 (16.7%) 2 6/17 (35.3%) 9
    General disorders
    Chills 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 3
    Edema face 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Edema limbs 1/6 (16.7%) 1 0/4 (0%) 0 1/6 (16.7%) 1 1/17 (5.9%) 1
    Fatigue 3/6 (50%) 6 2/4 (50%) 4 4/6 (66.7%) 7 11/17 (64.7%) 17
    Fever 4/6 (66.7%) 5 0/4 (0%) 0 1/6 (16.7%) 2 3/17 (17.6%) 6
    Injection site reaction 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Pain 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 6
    Hepatobiliary disorders
    Hepatic failure 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Infections and infestations
    Urinary tract NOS 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Skin infection 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Injury, poisoning and procedural complications
    Bruising 1/6 (16.7%) 1 1/4 (25%) 1 0/6 (0%) 0 0/17 (0%) 0
    Vascular access complication 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Wound dehiscence 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/6 (16.7%) 6 0/4 (0%) 0 2/6 (33.3%) 2 3/17 (17.6%) 5
    Alkaline phosphatase increased 1/6 (16.7%) 1 1/4 (25%) 1 1/6 (16.7%) 2 5/17 (29.4%) 7
    Aspartate aminotransferase increased 1/6 (16.7%) 1 0/4 (0%) 0 2/6 (33.3%) 2 6/17 (35.3%) 10
    Blood bilirubin increased 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 2
    Creatinine increased 0/6 (0%) 0 0/4 (0%) 0 2/6 (33.3%) 3 0/17 (0%) 0
    INR increased 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Neutrophil count decreased 5/6 (83.3%) 11 3/4 (75%) 6 2/6 (33.3%) 3 5/17 (29.4%) 6
    Platelet count decreased 4/6 (66.7%) 9 1/4 (25%) 3 3/6 (50%) 3 5/17 (29.4%) 9
    Weight gain 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Weight loss 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 3/17 (17.6%) 3
    White blood cell decreased 3/6 (50%) 13 0/4 (0%) 0 2/6 (33.3%) 2 5/17 (29.4%) 6
    Metabolism and nutrition disorders
    Anorexia 4/6 (66.7%) 5 0/4 (0%) 0 2/6 (33.3%) 2 6/17 (35.3%) 7
    Dehydration 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Hyperglycemia 1/6 (16.7%) 7 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Hyperkalemia 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Hypoalbuminemia 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 2 3/17 (17.6%) 4
    Hypoglycemia 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Hypokalemia 1/6 (16.7%) 3 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Hyponatremia 1/6 (16.7%) 3 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 1/17 (5.9%) 1
    Back pain 4/6 (66.7%) 4 0/4 (0%) 0 1/6 (16.7%) 1 5/17 (29.4%) 5
    Chest wall pain 1/6 (16.7%) 1 0/4 (0%) 0 1/6 (16.7%) 1 1/17 (5.9%) 1
    Generalized muscle weakness 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Muscle weakness lower limb 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Musculoskeletal and connective tissue disorder-not specified 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Myalgia 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Neck pain 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Pain in extremity 3/6 (50%) 3 0/4 (0%) 0 3/6 (50%) 3 0/17 (0%) 0
    Trismus 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders
    Dizziness 1/6 (16.7%) 1 0/4 (0%) 0 1/6 (16.7%) 1 2/17 (11.8%) 3
    Headache 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Memory impairment 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders - not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Peripheral motor neuropathy 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 1/17 (5.9%) 1
    Syncope 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Tremor 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 0/17 (0%) 0
    Psychiatric disorders
    Anxiety 1/6 (16.7%) 2 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Confusion 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Depression 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 3/17 (17.6%) 3
    Insomnia 0/6 (0%) 0 1/4 (25%) 1 2/6 (33.3%) 3 3/17 (17.6%) 3
    Renal and urinary disorders
    Cystitis noninfective 1/6 (16.7%) 2 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Proteinuria 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 2/17 (11.8%) 2
    Renal and urinary disorders - not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Urine discoloration 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Reproductive system and breast disorders
    Pelvic pain 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/6 (16.7%) 1 1/4 (25%) 1 3/6 (50%) 5 1/17 (5.9%) 1
    Dyspnea 2/6 (33.3%) 2 0/4 (0%) 0 2/6 (33.3%) 2 4/17 (23.5%) 4
    Epistaxis 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 2/17 (11.8%) 2
    Hiccups 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 1/17 (5.9%) 1
    Pleuritic pain 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Sinus disorder 2/6 (33.3%) 2 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Voice alteration 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 1/6 (16.7%) 1 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Hyperhidrosis 2/6 (33.3%) 2 0/4 (0%) 0 1/6 (16.7%) 2 0/17 (0%) 0
    Pain of skin 1/6 (16.7%) 2 0/4 (0%) 0 0/6 (0%) 0 0/17 (0%) 0
    Rash maculo-papular 1/6 (16.7%) 1 1/4 (25%) 3 0/6 (0%) 0 3/17 (17.6%) 5
    Skin and subcutaneous tissue disorders - not specified 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/17 (5.9%) 1
    Vascular disorders
    Hypertension 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 4/17 (23.5%) 5
    Hypotension 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2
    Phlebitis 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/17 (0%) 0
    Thromboembolic event 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 2/17 (11.8%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title George Albert Fisher, Associate Professor of Medicine, Stanford University
    Organization Stanford University
    Phone 650-725-9057
    Email georgeaf@stanford.edu
    Responsible Party:
    George Albert Fisher, Associate Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00185588
    Other Study ID Numbers:
    • IRB-06999
    • 95533
    • CPTK787AUS08
    • PANC0002
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Sep 15, 2014
    Last Verified:
    Sep 1, 2014