A Study of MM-111 in Combination With Multiple Treatments in Patients With HER2 Positive Cancer

Conditions

• HER-2 Gene Amplification

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cisplatin, Capecitabine, Trastuzumab and MM-111 — DRUG
  Conventional chemotherapy
• Lapatinib +/- Trastuzumab and MM-111 — DRUG
  Conventional chemotherapy
• Paclitaxel, Trastuzumab and MM-111 — DRUG
  Conventional chemotherapy
• Lapatinib, trastuzumab, paclitaxel, and MM-111 — DRUG
  Conventional chemo
• Docetaxel, trastuzumab and MM-111 — DRUG
  Conventional chemotherapy

Study Details

This study is an open-label, dose-escalation study of MM-111 with five different combination treatments with the main goal of determining the safety of MM-111 with each combination.

Key Dates

Start date

Jan 31, 2011

Status verified

Dec 2015

Primary completion

Apr 30, 2014

Completion

Jun 30, 2014

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Regimen follows a 3-week treatment cycle. Cisplatin 80mg/m2 given on day 1 by IV infusion over two hours every three weeks. Capecitabine 1000 mg/m2 given orally twice daily for fourteen days each 3-week cycle. Up to six 3-week cycles of Cisplatin and Capecitabine to be administered. Trastuzumab given as 8 mg/kg loading dose at week 1 over 90 minutes followed by 6 mg/kg every 3 weeks over 30-90 minutes. MM-111 will be administered over 90 minutes for the first infusion and then weekly over 60 minutes thereafter. Trastuzumab (every 3 weeks) and MM-111 (weekly) will continue until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Arm 2
  Regiment follows a 4-week treatment cycle. The following Lapatinib and Trastuzumab regimen will be given in combination with MM-111 in the following order: * Trastuzumab 4 mg/kg loading dose week 1 over 90 minutes * Followed by Trastuzumab 2 mg/kg weekly thereafter * Lapatinib 1000 mg by mouth (PO) daily * MM-111 will be administered over 90 minutes for the first infusion and then weekly over 60 minutes thereafter Treatment with this regimen will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Arm 3
  Regimen follows a 4-week treatment cycle Paclitaxel dosing should begin first dose on cycle 1 day 1. Paclitaxel will be administered at 80 mg/m2 weekly, as an IV infusion over 60 minutes. The infusion should be prepared as directed in the Paclitaxel package insert. All patients receiving Paclitaxel should be premedicated as per the local institutional guidelines. Trastuzumab will be administered via IV over 90 minutes at a 4 mg/kg loading dose for the first infusion followed by weekly infusion of 2 mg/kg over 60 minutes thereafter. MM-111 will be administered over 90 minutes for the first infusion and then weekly over 60 minutes thereafter. Treatment with this regimen will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Arm 4
  4-week treatment cycle. Lapatinib given orally. Paclitaxel dosing on cycle 1 day 1. Paclitaxel given at 80 mg/m2 weekly, as an IV infusion over 60 minutes. The infusion should be prepared as directed in the Paclitaxel package insert. All patients receiving Paclitaxel should be premedicated as per the local institutional guidelines. Trastuzumab given via IV over 90 minutes at a 4 mg/kg loading dose for the first infusion followed by weekly infusion of 2 mg/kg over 60 minutes thereafter. MM-111 given over 90 minutes for the first infusion and then weekly over 60 minutes thereafter. Treatment with this regimen will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Arm 5
  Docetaxel, trastuzumab and MM-111 3-week treatment cycles with therapies given in the following order: 1) docetaxel, 2) trastuzumab, and 3) MM-111 Docetaxel given as an IV infusion over 60 minutes every three weeks. The infusion should be prepared as directed in the Docetaxel package insert and any institutional guidelines. All patients receiving Docetaxel should be pre-medicated as per the local institutional guidelines. The first dose of trastuzumab is a loading dose of 8 mg/kg administered over 90 minutes followed by every three week dosing at 6 mg/kg over 60 minutes via IV infusion. The first dose of MM-111 given over 90 minutes followed by 3 week dosing over 60 minutes in the absence of infusion-related reactions

Primary Outcome Measure

Determine patient's safety (# of adverse events/serious adverse events) and tolerability of MM-111 in combination with multiple treatment regimens [ Time Frame: 30 months ]

Locations (15)

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