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PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Tarveda Therapeutics
Sponsor:
Information provided by (Responsible Party):
Tarveda Therapeutics
ClinicalTrials.gov Identifier:
NCT02936323
First received: October 13, 2016
Last updated: December 17, 2016
Last verified: December 2016
  Purpose
Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma of the lung.

Condition Intervention Phase
Neuroendocrine Tumors
Carcinoma, Small Cell Lung
Carcinoma, Large Cell Lung
Merkel Cell Carcinoma
Pheochromocytoma
Paraganglioma
Thyroid Cancer, Medullary
Neuroendocrine Carcinoma
Drug: PEN-221
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Open-label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEN-221 in Patients With Somatostatin Receptor 2 Expressing Advanced Cancers, Including Gastroenteropancreatic or Lung or Thymus or Other Neuroendocrine Tumors or Small Cell Lung Cancer or Large Cell Neuroendocrine Carcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Tarveda Therapeutics:

Primary Outcome Measures:
  • Treatment related adverse events [ Time Frame: From date of first treatment/trial entry until 28 days after last treatment, estimated 12 months ]
    Treatment related adverse events are assessed using CTCAE criteria.


Secondary Outcome Measures:
  • Maximum concentration of PEN-221 and its metabolites (Cmax) [ Time Frame: 2 months ]
    Maximum concentration of PEN-221 concentration in circulating blood

  • Area under the curve (AUC) of PEN-221 and its metabolites [ Time Frame: 2 months ]
    Area under PEN-221 concentration v time curve in circulating blood

  • Half-life (t1/2) of PEN-221 and its metabolites [ Time Frame: 2 months ]
    Half life of PEN-221 concentration in circulating blood

  • Tumor responses using RECIST criteria [ Time Frame: 2 months ]
    Size of tumors by CT or MRI (RECIST)

  • Radiographic progression free survival [ Time Frame: From date of first treatment/trial entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to (estimated) 36 months ]
    Size of tumors by CT or MRI (RECIST)

  • Overall survival [ Time Frame: From date of first treatment/trial entry until the date of date of death from any cause, assessed up to (estimated) 36 months ]
    Time to death


Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEN-221
intravenous administration of PEN-221
Drug: PEN-221
Administration of PEN-221 once every three weeks

Detailed Description:

Protocol PEN-221-001 will first enroll patients into a dose escalation phase, where a Bayesian logistic regression model, guided by the escalation with overdose control principle and overseen by a safety review committee, will be used to make dose recommendations and estimate the maximum tolerated dose (MTD).

Once the MTD has been determined, additional patients will be enrolled into an early expansion phase to confirm or adjust the MTD.

Once the MTD has been confirmed, remaining patients will be enrolled into a full expansion phase to assess PEN-221 efficacy.

  Eligibility

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

Inclusion Criteria:

  • M/F at least 18 years old
  • Performance status 0 or 1
  • Adequate bone marrow, liver, and kidney function within 2 weeks prior to first dose
  • Serum potassium, calcium, magnesium, phosphorus within normal limits (may be supplemented)
  • Adequate birth control
  • Somatostatin receptor 2 positive tumor as assessed at pre-screening or within 180 d of first drug administration using indium SPECT or gallium PET
  • Histologically or cytologically confirmed solid tumor in categories:
  • Advanced small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) of lung progressed after at least 1 line of anticancer chemotherapy
  • Advanced low or intermediate grade gastroenteropancreatic or lung or thymus neuroendocrine tumor (NET), or NET of unknown primary, progressed after at least 1 line of anticancer therapy (unless no standard treatments available or such treatments are deemed not appropriate)
  • Advanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel cell carcinoma, or high grade extrapulmonary neuroendocrine carcinoma
  • For patients enrolling once escalation is complete, disease must be measurable per RECIST 1.1 criteria with last imaging performed within 28 days prior to first drug dose

Exclusion Criteria:

  • Treatment with anticancer therapy or investigational drug or device within 3 wk (6 wk for nitrosureas or mitomycin C) or 5 half-lives of agent, whichever is shorter, prior to first drug dose, and any drug-related toxicities must have recovered to grade 1 or less
  • Any other malignancy known to be active or treated within 3 years of start of screening, except cervical intra-epithelial neoplasia and non-melanoma skin cancer
  • Cardiac criteria such as unstable angina, myocardial infarction within 6 months of screening, NY Heart Association Class 1 or 2 heart failure, QTc greater than 470 msec, congenital long Qt syndrome, symptomatic orthostatic hypotension within 6 months of screening, uncontrolled hypertension, or clinically important abnormalities in heart rhythm, conduction, morphology of resting ECG
  • Stroke or transient ischemic attack within 6 months of screening
  • Peripheral neuropathy greater than grade 1
  • Requirement for medication with strong CYP3A4 inhibitor
  • History of leptomeningeal disease or spinal cord compression
  • Brain metastases unless asymptomatic and not requiring steroids for at least 4 weeks prior to start of study treatment (Patients with SCLC or LCNEC of lung only must have CT or MRI of brain during screening, and if metastases found, must have radiotherapy with 14 day washout or stereotactic radiotherapy or radio surgery with 7 day washout)
  • Major surgery within 28 days of first drug dose
  • Female pregnant or breast feeding
  • Evidence of severe uncontrolled systemic disease, bleeding diatheses, renal or liver transplant, active infection with hep B or C or HIV
  • Hypersensitivity or anaphylactic reaction to any somatostatin analog or to maytansinoids
  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: NCT02936323

Contacts
Contact: Tarveda Clinical Information Center clinical.information@tarveda.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University Medical Center/ NY Presbyterian Recruiting
Manhattan, New York, United States, 10032
United States, Tennessee
Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tarveda Therapeutics
Investigators
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Tarveda Therapeutics
ClinicalTrials.gov Identifier: NCT02936323     History of Changes
Other Study ID Numbers: PEN-221-001
Study First Received: October 13, 2016
Last Updated: December 17, 2016

Keywords provided by Tarveda Therapeutics:
SCLC small cell lung cancer neuroendocrine NET

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma
Small Cell Lung Carcinoma
Thyroid Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Paraganglioma
Carotid Body Tumor
Carcinoma, Merkel Cell
Pheochromocytoma
Carcinoma, Neuroendocrine
Carcinoma, Small Cell
Carcinoma, Large Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on March 23, 2017