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Completed

NCT Number: NCT01352884

Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer

This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult patients with cancer that is not responding to standard therapy. This study will be conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.

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Key information

Conditions

Cancer Carcinoma Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karmanos Cancer Institute, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to provide informed consent
  • In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists
  • In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or cytologically confirmed
  • Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and must not have received more than 2 prior chemotherapeutic regimens
  • Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV disease that is surgically incurable and unresectable
  • Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors
  • Must have measurable disease
  • Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry
  • Must by at least 18 years old
  • Must have adequate organ function

Exclusion criteria

  • Prior cancer therapies must have completed at least 14 days or 5 half-lives (whichever is longer) prior to first dose of AMP-224
  • Prior treatment with an anti-PD1 antibody therapy
  • Known antibody response against prior antibody therapy or fusion protein therapeutics
  • Major surgery within 4 weeks prior to first dose of AMP-224
  • Prior allogeneic or autologous bone marrow or organ transplantation
  • Known and/or a history or evidence of autoimmune disease except vitiligo, resolved childhood asthma and stable hypothyroidism
  • Received an immunomodulatory drug within 2 weeks of first dose of AMP-224
  • Active infections requiring antibiotics, physician monitoring, or recurrent fevers >100.4 degrees fahrenheit associated with a clinical diagnosis of active infection
  • Patients with cirrhosis
  • Clinically significant cardiac or electrocardiogram abnormalities
  • History or evidence of HIV
  • Active viral disease (except when the viral infection is associated with the malignancy)
  • Regular use of illicit drugs or a recent history of substance abuse
  • Pregnant or breastfeeding women

Treatment and study plan

AMP-224

Drug

Escalating doses of AMP-224

Primary outcomes

  1. Number of participants with adverse events.

    Time frame: From start of study drug administration until the date of first documented progression or date of death from any cause; through Day 56 of final cycle.

  2. Number of participants with dose-limiting toxicities.

    Time frame: From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.

  3. Number of participants with changes in laboratory values, vital signs, physical exam, and electrocardiogram.

    Time frame: From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.

  4. Determine Maximum Tolerated Dose based on the occurrence of dose-limiting toxicities.

    Time frame: From start of study drug administration through Day 28 of Cycle 1.

  5. Determine Recommended Phase 2 Dose following analysis of adverse events, pharmacokinetics and changes in laboratory evaluations.

    Time frame: From start of study drug administration until withdrawal; through Day 56 of final cycle.

Secondary outcomes

  1. Evaluate pharmacokinetics, including area under the plasma concentration versus time curve (AUC), peak plasma concentration (Cmax) and clearance of AMP-224 following single and repeat doses of AMP-224.

    Time frame: From Day 0 pre-dose through Day 56 of final cycle.

  2. Evaluate Overall Response Rate (ORR), including Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression-Free Survival (PFS).

    Time frame: From Screening through 12 weeks following final cycle.

  3. Characterization of the effects of AMP-224 on its receptor, PD-1, in peripheral T cells via flow cytometry and correlate with response to treatment.

    Time frame: From Screening until 12 weeks post-final cycle.

  4. Evaluation and correlation between response to treatment and expression of PD-1 on tumor infiltrating T cells or in available malignant pleural effusions via flow cytometry and/or immunohistochemistry.

    Time frame: Screening through 12 weeks post-final cycle.

  5. Evaluation and correlation between response to treatment and expression of B7-H1 on tumors via immunohistochemistry.

    Time frame: Screening through 12 weeks post-final cycle.

  6. Identification of peripheral patient selection and pharmacodynamic markers from blood samples that predict and/or correlate with response to treatment.

    Time frame: Screening through 12 weeks post-final cycle.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 12, 2011
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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