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Phase 1 Safety and Tolerability Study of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Andes Biotechnologies
Sponsor:
Information provided by (Responsible Party):
Andes Biotechnologies
ClinicalTrials.gov Identifier:
NCT02508441
First received: July 15, 2015
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Condition Intervention Phase
Advanced Unresectable Solid Tumors Drug: Andes-1537 for Injection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label First-in-human Dose-escalating Safety and Tolerability Study Evaluating Subcutaneous Administration of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy is Available

Further study details as provided by Andes Biotechnologies:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities [ Time Frame: First 4-week treatment cycle ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537 (expected average time frame of up to 6 months) ]
  • Safety laboratory tests [ Time Frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537 (expected average time frame of up to 6 months) ]
  • Physical examinations [ Time Frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537 (expected average time frame of up to 6 months) ]
  • Vital signs [ Time Frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537 (expected average time frame of up to 6 months) ]
  • 12-lead electrocardiogram (ECG) [ Time Frame: First 4-week treatment cycle ]
  • Injection site reactions [ Time Frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537 (expected average time frame of up to 6 months) ]
  • Pharmacokinetic parameters in Andes-1537 in blood and urine for single-dose and multiple-dose evaluation [ Time Frame: Pre-treatment, following first dose and last dose of cycle 1 (4-week cycle), first dose of each additional cycle through study completion, and last visit (expected average time frame of up to 6 months) ]
    Measure maximum concentration, time to maximum concentration, area under the curve, clearance, volume of distribution, and half-life

  • Pharmacodynamic parameters in blood and biopsy samples from accessible tissue [ Time Frame: Pre-treatment and at 4 and 8 weeks for biopsy; blood samples at pre-treatment, every 8 weeks, and last visit (expected average time frame of up to 6 months). Biopsies will be optional in Part 1 and mandatory in Part 2. ]
    Detection of apoptosis, survivin, and proliferating cell nuclear antigen in biopsy samples

  • Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) with CT or MRI scan. Measurement of tumor markers (PSA or CA-125), if applicable for type of solid cancer. [ Time Frame: Every 8 weeks following completion of 2 treatment cycles and at the last visit to cover from date of randomization until date of first documented progression or toxicity to Andes-1537, which ever comes first, up to 6 months ]

Estimated Enrollment: 91
Study Start Date: December 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Andes-1537 for Injection
Part 1 is an open-label, dose-escalation study. Part 2 is an open-label, dose-expansion study.
Drug: Andes-1537 for Injection

Part 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle

Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle


Detailed Description:
Part 1 is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available. Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 in patients with advanced solid tumors. In part 2, patients will be enrolled and receive the recommended phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 years of age or older
  • Can understand and voluntarily sign an informed consent form prior to any study-related assessments or procedures, and are able to adhere to the study visit schedule and other protocol requirements
  • Patient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is available
  • Consent to tumor biopsy from accessible tissue (optional in part 1, mandatory in part 2)
  • Part 2 only: have measureable disease by RECIST
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Have adequate organ function, confirmed by the following laboratory values obtained ≤ 3 days prior to the first treatment: absolute neutrophil count ≥ 1.5 × 10^9/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100 × 10^9/L; aspartate transaminase and alanine transaminase ≤ 2.5 × upper limit of normal (ULN); serum total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN, or estimated or measured creatinine clearance ≥ 60 mL/min; prothrombin time, activated partial thromboplastin time ≤ 1.5 × ULN if not on anticoagulation therapy
  • Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug.
  • Male patients at screening must agree to practice adequate contraception from study entry through at least 6 months after discontinuation of study drug.

Exclusion Criteria:

  • Have symptomatic central nervous system metastases. Patients with brain metastases that have been previously treated and are stable for ≥ 4 weeks or treated with gamma knife surgery and are stable for ≥ 2 weeks are allowed to enter the study.
  • Have unstable angina, clinically significant cardiac arrhythmia, New York Heart Association Class 3 or 4 congestive heart failure, or prolonged QT interval corrected wave of greater than 470 ms.
  • Receiving treatment with any medication known to produce QT prolongation within 7 days of study entry
  • Have had prior systemic chemotherapy treatments or investigational modalities ≤ 5 half-lives or 4 weeks, whichever is shorter, prior to starting treatment with Andes-1537 or who have not recovered from side effects, grade 2 or greater, of such therapy (except alopecia)
  • Have had major surgery ≤ 2 weeks prior to starting treatment with Andes-1537 or who have not recovered from side effects of such surgery
  • Are pregnant or breastfeeding
  • Have had DVT or venous thromboembolism within 6 weeks of study entry
  • Have active uncontrolled bleeding or a known bleeding disorder
  • Have any serious or unstable concomitant systemic conditions that are incompatible with this clinical study, including but not limited to substance abuse, psychiatric disturbance, or uncontrolled intercurrent illness (including active infection), arterial thrombosis, or symptomatic pulmonary embolism
  • Have a known sensitivity to any of the components of Andes-1537
  • Are unable or unwilling to follow protocol instructions and requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02508441

Contacts
Contact: Pamela Munster, MD 415-885-7810 Pamela.Munster@ucsf.edu

Locations
United States, California
UCSF Medical Center at Mount Zion, Helen Diller Family Comprehensive Cancer Center, Early Phase Clinical Trials Recruiting
San Francisco, California, United States, 94115
Contact: Kamran Abri Lavasani    415-514-6245    Kamran.AbriLavasani@ucsf.edu   
Principal Investigator: Pamela Munster, MD         
Sponsors and Collaborators
Andes Biotechnologies
Investigators
Principal Investigator: Pamela Munster, MD University of California, San Francisco
  More Information

Responsible Party: Andes Biotechnologies
ClinicalTrials.gov Identifier: NCT02508441     History of Changes
Other Study ID Numbers: AB1537-001
Study First Received: July 15, 2015
Last Updated: February 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andes Biotechnologies:
Neoplasms
Solid Tumors
Advanced Malignancy
Cancer

ClinicalTrials.gov processed this record on August 18, 2017