Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

NCT01580397 | Completed Phase 2 Results

• 1 other identifier: INNO-206-P2-PDA-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

Brief Summary

Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic cancer; INNO-206; Doxorubicin-EMCH

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective responses were evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (ie, improvements) in tumor measurements from baseline values were assigned a status of CR or PR or SD. Objective response measurements comprised the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.

  Approximately 12 months from enrollment

Secondary Outcomes (1)

• Number of Participants With Treatment-related Toxicities (Adverse Events)

  30 days after last dose, up to 178 days

Study Arms (1)

INNO-206

EXPERIMENTAL

INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.

Drug: INNO-206

Interventions

INNO-206 DRUG

INNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.

Also known as: Aldoxorubicin

INNO-206

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years of age; male or female.
• Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic pancreatic ductal adenocarcinoma.
• Cancer progression after treatment with one gemcitabine and one fluoropyrimidine-containing chemotherapy regimen.
• Capable of providing informed consent and complying with trial procedures.
• ECOG performance status 0-1.
• Life expectancy ≥ 8 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Geographic accessibility to the site.

You may not qualify if:

• Prior exposure to \> 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
• Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization.
• Exposure to any investigational agent within 30 days of Randomization.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 5 years.
• Laboratory values: Screening serum creatinine \> 1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) \> 3×ULN or \> 5×ULN if liver metastases are present, total bilirubin \> 3×ULN, absolute neutrophil count \< 1,500/mm3, platelet concentration \< 100,000/mm3, absolute lymphocyte count \< 1000/mm3, hematocrit level \< 27% for females or \< 30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \> 1.5×ULN, serum albumin ≤ 2.8 g/dL.
• Clinically evident congestive heart failure \> class II of the New York Heart Association (NYHA) guidelines.
• Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
• History or signs of active coronary artery disease with or without angina pectoris.
• Serious myocardial dysfunction ultrasound-determined, with absolute left ventricular ejection fraction (LVEF) \< 45% of predicted.
• History of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
• Major surgery within 4 weeks prior to Randomization.
• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the subject's participation in the study.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (6)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407-3799, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Medical College of Wisconsin - Division of Neoplastic Diseases and Related Disorders

Milwaukee, Wisconsin, 53266, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

DOXO-EMCH

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Study Officials

• Daniel Von Hoff, MD, FACP

  Translational Genomics Research Institute

  PRINCIPAL INVESTIGATOR

• Daniel Levitt, MD, PhD

  CytRx

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 19, 2012
• Study Start: May 16, 2012
• Primary Completion: May 13, 2013
• Study Completion: July 2, 2013
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2013-06

Locations

US (6)