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Urothelial CarcinomaPhase 2NCT01907308

Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma

A Phase 2 study testing AMG 386 and Docetaxel in people with Urothelial Carcinoma, run by University of Colorado, Denver.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study plans to learn more about the combination of AMG 386 and docetaxel for the treatment of advanced urothelial cancer. Subjects are being asked to be in this research study because they have advanced urothelial cancer which has progressed after treatment with a platinum-based therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
AMG 386 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2014to Apr 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have a histologically confirmed urothelial carcinoma. At least 50% of the tumor must demonstrate transitional cell histology.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • CT or MRI of the chest, abdomen, and pelvis, with or without contrast, within 28 days of registration. A whole body bone scan may be performed at the discretion of the treating physician.
  • Only if clinically indicated, a CT or MRI (MRI preferred) scan of the brain within 28 days of registration.
  • Progressive disease after a platinum-containing regimen (cisplatin or carboplatin) or intolerance to platinum-based therapy for urothelial carcinoma. Subjects who received adjuvant cisplatin or carboplatin-based chemotherapy for urothelial carcinoma and currently have recurrent or progressive disease are eligible.
  • Men or women > 18 years old
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  • Generally well-controlled blood pressure with systolic blood pressure ≤ 140 mmHg AND diastolic blood pressure ≤ 90 mmHg prior to enrolment or randomization. The use of anti-hypertensive medications to control hypertension is permitted
  • Adequate organ and hematological function as evidenced by the following laboratory studies:
  • Hematological function, as follows: i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelet count ≥ 100 x 109/L iii. Hemoglobin ≥= 9 g/dL b. Hepatic function, as follows: i. Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), ii. Alanine aminotransferase (ALT) ≤ 2.5 x ULN iii. Alkaline phosphatase ≤ 2.0 x ULN iv. Total bilirubin within normal limits (WNL) c. Hemostatic function, as follows: i. International normalized ratio (INR) ≤ 1.5 ii. Activated Partial thromboplastin time (aPTT) ≤ 1.5 x ULN d. Renal function, as follows: i. Calculated creatinine clearance ≥ 40 cc/min according to the Cockcroft-Gault formula: Creatinine Clearance calculator (CrCl) (mL/min) = (140-age) x actual body weight (kg) (x 0.85 for females) 72 x serum creatinine (mg/dL) ii. Urinary protein quantitative value of ≤ 30 mg in urinalysis or ≤ 1+ on dipstick, unless quantitative protein is ≤ 1000 mg in a 24 hour urine sample e. Cardiac function, as follows (only in those with a known history of cardiac dysfunction or in those with symptoms indicative or cardiac dysfunction): i. Normal sinus rhythm or clinically stable arrhythmia well controlled on outpatient medication.
  • Left ventricular ejection fraction ≥ lower limit of normal (LLN) per institutional laboratory range, as determined by echocardiogram or multi gated acquisition scan (MUGA) scan within 28 days prior to enrollment. If no clear institutional standard, then the ejection fraction must be ≥ 50%.
  • All baseline laboratory results must be from within 14 days of registration
  • Competent to comprehend, sign, and date an institutional review board (IRB) - approved informed consent form
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Subject plans to begin protocol-directed therapy within 7 days of registration
  • All patients will be offered enrollment in the correlative biomarkers study

Who cannot join

  • Three or more previous systemic therapies or combination regimens for urothelial carcinoma (e.g. cisplatin given with gemcitabine is considered one regimen) in the recurrent or metastatic setting.
  • Grade 2 or greater neuropathy
  • Known history of central nervous system metastases. An MRI or CT scan of the brain will be performed within 28 days of study enrollment.
  • History of arterial or venous thrombosis, including transient ischemic attack (TIA), within 12 months prior to enrollment
  • History of clinically significant bleeding within 6 months of study enrollment
  • Anticoagulation is allowed as long as the initiating thrombotic event was at least 12 months before enrollment. The use of aspirin and anti-platelet agents are also acceptable for any duration prior to enrollment. The concurrent use of low molecular weight heparin, heparinoids, or low dose warfarin (ie, 1 mg daily) for prophylaxis against thrombosis is acceptable while on study.
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  • Subjects with pleural effusions or ascites.
  • Focal radiation therapy for palliation of pain from bony metastases within 21 days of study enrollment. Subjects who received radiation therapy must have recovered from all radiation induced toxicities prior to study enrollment
  • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor including but not limited to, AZD-5180, XL-820, CEP 11981/SSR-106462, BSF-466,895, CGI-1842, LOC-590, XL-184, or CP- 8681596. (Previous treatment with bevacizumab is permitted.)
  • Current or previous treatment with docetaxel. (Previous treatment with paclitaxel is permitted.)
  • Treatment within 30 days prior to enrollment with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide.
  • Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication
  • Major surgery within 28 days before study enrollment or still recovering from prior surgery
  • Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to enrollment/randomization.
  • Non-healing wound, ulcer (including gastrointestinal) or fracture
  • Pregnant (i.e., positive beta-human chorionic gonadotropin test) or current breast feeding
  • Subjects with a history of prior malignancy, except:
  • Malignancy treated with curative intent and with no known active disease present for > 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
  • Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Prostatic intra-epithelial neoplasia without evidence of prostate cancer
  • Subject known to have tested positive for HIV or chronic hepatitis
  • Any condition which in the investigator's opinion makes the subject unsuitable for study participation
  • Female subject not consenting to the use of contraceptive method during the course of the study and for 6 months after administration of the last study medication
  • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s). Alternatively, for any recently administered investigational drugs, subjects may start treatment on this protocol after 4 half-lives of the previous investigational agent.
  • Subject has known sensitivity to any of the products to be administered during dosing (including any reaction to drugs formulated with polysorbate 80)
  • History of allergic reactions to bacterially produced proteins
  • Life expectancy of less than 3 months.

About this study

Official title: A Phase II Single-arm Study of AMG 386 in Combination With Docetaxel for Advanced Urothelial Carcinoma After Failure of a Platinum-containing Regimen

This study plans to learn more about the combination of AMG 386 and docetaxel for the treatment of advanced urothelial cancer. Subjects are being asked to be in this research study because they have advanced urothelial cancer which has progressed after treatment with a platinum-based therapy.

The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a single agent.

Read the detailed description

AMG 386 is a medication made to stop the growth of blood vessels in cancer tissues. Cancer relies on new blood vessels to bring it oxygen and nutrients to grow. Docetaxel is currently approved by the FDA for advanced urothelial, hormone-refractory prostate, breast, non-small cell lung, gastric, and squamous cell carcinoma of the head and neck.

Being tested
AMG 386, Docetaxel
Keywords
Bladder cancer, Urothelial cancer, Urothelial carcinoma
Medical subject headings
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 386Drug

    Also called Trebananib

    Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks.

  • DocetaxelDrug

    Also called Docefrez, Taxotere

    Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks.

Study groups in NCT01907308
Study groupRoleWhat they receive
Combination of AMG 386 with DocetaxelExperimentalAll treated patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks.
Receives: Drug: AMG 386; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Determine the objective response rate (by RECIST 1.1 criteria) for the combination of AMG 386 (Trebananib) with docetaxel for the treatment of advanced or metastatic urothelial carcinoma, after failure of a platinum-containing regimen

    Measured: Up to 21 days

Secondary outcomes (1)

  1. Overall survival

    Determine the overall survival for the combination of AMG 386 with docetaxel in advanced or metastatic urothelial carcinoma

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: Sponsor's decision to terminate the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01907308
Sponsor's protocol ID
13-1502.cc
Other IDs
NCI-2013-01348
Status last verified
Apr 2014
First submitted
16 Jul 2013
Last updated
29 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 386 and Docetaxel in people with Urothelial Carcinoma, run by University of Colorado, Denver.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01907308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.

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