QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

NCT00807612 | Terminated Phase 1 Results

• 2 other identifiers: 20080257QUILT-2.017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 25

Brief Summary

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

Conditions

Advanced Squamous Non-Small Cell Lung Cancer

Keywords

AMG 479; IGF-1R; Apoptosis; Monoclonal Antibody; Advanced Squamous Non-Small Cell Lung Cancer; antibody 1st-line

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Dose Limiting Toxicities

  DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.

  Part 1 only up to 21 days

• Part 2: Objective Response Rate

  Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From start of treatment up to approximately 16 months

Secondary Outcomes (4)

• Number of Participants With Adverse Events

  30 days after last dose, up to 5 months

• Number of Participants With Anti-AMG 479 Antibody Formation

  From start of treatment up to approximately 16 months

• Progression Free Survival

  From start of treatment up to approximately 16 months

• Time to Progression and Duration of Response

  From start of treatment up to approximately 16 months

Study Arms (3)

Part 1 Cohort 1

EXPERIMENTAL

AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1

Biological: AMG 479; Drug: Carboplatin; Drug: Paclitaxel

Part 1 Cohort 2

EXPERIMENTAL

AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1

Biological: AMG 479; Drug: Carboplatin; Drug: Paclitaxel

Part 2

EXPERIMENTAL

AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1 (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)

Drug: Carboplatin; Biological: AMG 479; Drug: Paclitaxel

Interventions

AMG 479 BIOLOGICAL

AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1

Part 1 Cohort 2

Carboplatin DRUG

Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6

Part 1 Cohort 1; Part 1 Cohort 2; Part 2

Paclitaxel DRUG

Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6

Part 1 Cohort 1; Part 1 Cohort 2; Part 2

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed advanced squamous NSCLC
• Measurable disease as defined per modified RECIST criteria
• ECOG performance status of 0 or 1
• ≥18 years old
• Adequate glycemic function, for subjects with known diabetes

You may not qualify if:

• Untreated or symptomatic central nervous system (CNS) metastases
• Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC

Sponsors & Collaborators

• NantCell, Inc.: lead

Study Sites (25)

Research Site

Fayetteville, Arkansas, 72703, United States

Location

Research Site

Fayetteville, Arkansas, United States

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Research Site

Fort Wayne, Indiana, 46845, United States

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Research Site

Fort Wayne, Indiana, United States

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Research Site

Indianapolis, Indiana, 46202, United States

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Research Site

Indianapolis, Indiana, 46256, United States

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Research Site

Indianapolis, Indiana, United States

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Research Site

Lafayette, Indiana, 47905, United States

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Research Site

Lafayette, Indiana, United States

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Research Site

New Albany, Indiana, 47150, United States

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Research Site

New Albany, Indiana, United States

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Research Site

Paducah, Kentucky, 42003, United States

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Research Site

Paducah, Kentucky, United States

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Research Site

St Louis, Missouri, 63110-1093, United States

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Research Site

St Louis, Missouri, United States

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Research Site

Winston-Salem, North Carolina, 27103, United States

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Research Site

Winston-Salem, North Carolina, United States

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Research Site

Bethlehem, Pennsylvania, 18015, United States

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Research Site

Bethlehem, Pennsylvania, United States

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Research Site

Greenville, South Carolina, 29605, United States

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Research Site

Greenville, South Carolina, United States

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Research Site

Memphis, Tennessee, 38120, United States

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Research Site

Memphis, Tennessee, United States

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Research Site

Madison, Wisconsin, 53792, United States

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Research Site

Madison, Wisconsin, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Insulin-Like Growth Factor I, Resistance To

Interventions

ganitumab; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

There was a small number of subjects enrolled (15, only 14 treated) compared to the planned sample size (up to 52) and small number of responses/events occurring which could introduce bias in interpretation of the results and potentially misleading conclusions.

Results Point of Contact

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

Bobby.Reddy@immunitybio.com

855-797-9277

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: January 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Locations

US (25)