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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Advan

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Tarveda Therapeutics

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Tarveda Therapeutics

Dates:
Date Received: October 13, 2016
Date Started: December 8, 2016
Date Completion: December 2019
Last Updated: May 21, 2017
Last Verified: May 2017