Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib in combination with an anti-cancer agent — DRUG
  Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
• Lapatinib — DRUG
  Lapatinib monotherapy
• Lapatinib in combination with an anti-cancer agent as specified by parent protocol — DRUG
  Lapatinib in combination with an anti-cancer agent as specified by parent protocol

Study Details

This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.

Key Dates

Start date

Oct 31, 2008

Status verified

Feb 2018

Primary completion

Aug 19, 2016

Completion

Aug 19, 2016

Study Design

Enrollment

500 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1
  Study Drug
• Experimental: Group 2
  Study Drug

Primary Outcome Measure

Safety and tolerability [ Time Frame: Initiation of study treatment to discontinuation of study treatment ]

Locations (15)

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