Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue

NCT03629847 | Unknown Phase 1 DMC

• 1 other identifier: 2121-159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

NET originate in neuroendocrine cells throughout the body. The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy as a 1st line therapy in unresectable well to moderately differentiated metastatic neuroendocrine tumors of all GI, lung and pancreatic origins. This is a phase 1 - 2 study. The phase 1 part involves finding the maximum tolerating dose (MTD) of Everolimus.

Conditions

Neuroendocrine Tumors

Keywords

NETs, MTD, Everolimus.

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment related adverse events

  Establish safety profile of the combination of everolimus and intravenous radiolabeled Lu-177 DOTATATE

  "3 years"

Secondary Outcomes (1)

• Survival assessment

  3 years

Study Arms (1)

Everolimus & Radiolabeled Lu-177

EXPERIMENTAL

Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Drug: Everolimus

Interventions

Everolimus DRUG

Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Also known as: Radiolabeled Lu-177 DOTATATE

Everolimus & Radiolabeled Lu-177

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old.
• Histologically confirmed well to moderately differentiated neuroendocrine tumors of GI, lung or pancreatic origin. The grading follows the WHO grading system (Appendix III).
• Measurable disease by CT or MRI.
• Positive Tc-99m Octreotide scan or Ga-68 Octreotate scan (Positive means uptake at tumor sites).
• Advanced disease which are not treatable by surgical resection.
• Documented progressive disease within the past 12 months.
• WHO Performance Status 0 - 2.
• Fasting blood sugar ≤ 1.5 Χ Upper Limit of Normal (ULN).
• Fasting triglycerides ≤ 2.5 Χ Upper Limit of Normal (ULN), and fasting cholesterol ≤ 300 mg/dl or ≤ 7.75 ml/l.
• Adequate renal function with creatinine clearance ≥ 60 ml/l.
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 Χ Upper Limit of Normal (ULN)
• Liver Function Tests (Serum aspartate aminotransferase and alanine transaminase levels) ≤ 2.5 Χ ULN (and ≤ 5 Χ ULN, in case of presence of liver metastasis)
• Adequate hematological values:
• Absolute neutrophil count ≥ 1 x 109/L

You may not qualify if:

• Readily completely Resectable disease.
• Prior therapy with everolimus or systemic chemotherapy.
• Prior chemoembolization, radio-embolization, or bland embolization within 6 months before enrolment. Likewise, patients are ineligible if had undergone conventional radiotherapy, radiofrequency ablation, cryoablation or alcohol injection within 1 month prior to enrolment.
• Prior long acting somatostatin analogue within 1 month prior to enrolment. Short acting somatostatin analogue is allowed as long as it is not administered within 12 hours before or /and 12 hours after the administration of the intravenous radiolabelled Lu-177 DOTATATE Therapy.
• Presence of Central Nervous System metastasis.
• Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer
• Other active malignancy.
• HIV infection.
• Severe or uncontrolled medical conditions, such as:
• Active uncontrolled severe infection
• History of invasive fungal infection.
• Child C liver dysfunction.
• Severely impaired lung function.
• Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
• Any psychological, familial, geographic or social circumstances which could impair the patient's ability to participate in the trial and comply with follow up.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

Oncology Centre, King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Metatropic dwarfism

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Ali Aljubran, MD

  KFSH&RC

  PRINCIPAL INVESTIGATOR

• Fazal Hussain, MD

  KFSH&RC

  STUDY DIRECTOR

Central Study Contacts

Ali Aljubran, MD

CONTACT

966-11-4647272; ajubran@kfshrc.edu.sa

Shouki Bazarbashi, MD

CONTACT

966-11-4423799; bazarbashi@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: August 14, 2018
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

SA (1)